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Integra™ Omni-Tract® Table Mounted Abdominal Retractor System - HSA Registration DE0014422

Access comprehensive regulatory information for Integra™ Omni-Tract® Table Mounted Abdominal Retractor System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014422 and owned by Integra LifeSciences Corporation. The device was registered on December 04, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0014422
Integra™ Omni-Tract® Table Mounted Abdominal Retractor System
HSA Registration Number: DE0014422
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Product Description

An assembly of devices used to create a self-locking mechanism to temporarily part tissue (e.g., hold the edges of a wound open), or other anatomical structures, to expose internal tissues or organs for access during surgery. The assembly may be anchored to the operating room table and may include devices such as horizontal bars, rings, ratchet mechanisms, fibreoptic lights, various attachment devices, and a variety of retractor blades. The component parts are typically made of metal and are reusable after sterilization.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00109
HS Code
90189090
Registration Information
Registration Number
DE0014422
Registration Date
December 04, 2013
Retention Due Date
December 03, 2025
Product Owner
Short Name
Integra LifeSciences
Address
311 Enterprise Drive, Plainsboro, NJ 08536, UNITED STATES
Registrant
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model Information
Model Name(s)
OMNI-FLEX STERILE FIELD POST Small WISHBONE Arm Strap Clamp OmniAccess Sterile Field Post w/Universal Denyer Maquet Jaw Sterile Field Post w/Universal Denyer Maquet Jaw Double Clamp SF Post w/Universal Denyer Maquet Jaw OMNI-FLEX SUPPORT ARM Extension Arm (0.75" diameter), 20" (51cm) SideSnap™ Articulating Blade Holder (ABH) Omni-Flex Replacement Straps-12", Bag of 12 Omni-Flex Replacement Straps-27", Bag of 12 SPEED-TRACT SUPPORT ARM Speed-Tract, 1" x 1" Coupler ALUMINUM DEAVER RADIOLUCENT BLADE, 2.75" X 4.5" (7CM X 11.4CM) ALUMINUM MALLEABLE RADIOLUCENT BLADE, 2.0" X 6.5" (5CM X 16.5CM) ALUMINUM MAYO RADIOLUCENT BLADE, 2.75" X 2.0" (7CM X 5CM) ALUMINUM MAYO RADIOLUCENT BLADE, 3.5" X 2.0" (9CM X 5CM) ALUMINUM RENAL RADIOLUCENT BLADE, 1.0" X 4.0" (2.5CM X 10.2CM) ALUMINUM RENAL RADIOLUCENT BLADE, 1.0" X 6.0" (2.5CM X 15.2CM) ALUMINUM RENAL RADIOLUCENT BLADE, 1.0" X 8.0" (2.5CM X 20.3CM) ALUMINUM SPLANCHNIC RADIOLUCENT BLADE, 2.0" X 4.5" (5CM X 11.4CM) ALUMINUM SPLANCHNIC RADIOLUCENT BLADE, 2.0" X 6.0" (5CM X 15.2CM) Speed-Tract, Sterile Field Post, w/Coupler - 18" GHOSTRACT SQUARE BLADE HOLDER ASSEMBLY Speed-Tract, Sterile Field Post, w/Coupler - 24" GHOSTRACT TRAY AND COVER ASSEMBLY ROUND BLADE HOLDER ASSEMBLY, GHOSTRACT BALFOUR SWIVEL RETRACTOR, SQUARE SHAFT, 2.75" X 3.0" (7CM X HARRINGTON SWIVEL RETRACTOR, SQUARE SHAFT, 2.5" X 7.0" (6.3C KELLY SWIVEL RETRACTOR, SQUARE SHAFT, 2" X 3" (5CM X 7.6CM) KELLY SWIVEL RETRACTOR, SQUARE SHAFT, 2" X 4" (5CM X 10.2CM) KELLY SWIVEL RETRACTOR, SQUARE SHAFT, 2" X 5" (5CM X 12.7CM) KELLY SWIVEL RETRACTOR, SQUARE SHAFT, 2" X 6" (5CM X 15.2CM) MALLEABLE SWIVEL RETRACTOR, SQUARE SHAFT, 1.5" X 6.0" (3.8CM MALLEABLE SWIVEL RETRACTOR, SQUARE SHAFT, 2.0" X 6.5" (5CM X MALLEABLE SWIVEL RETRACTOR, SQUARE SHAFT, 3.0" X 6.5" (7.6CM MEDIUM ROUND RING, LITE MEDIUM OVAL RING, LITE LARGE OVAL RING, LITE RATCHET-BALL ASSEMBLY BALFOUR FIXED RETRACTOR, SQUARE SHAFT, 2.75" X 3.0" HARRINGTON FIXED RETRACTOR, SQUARE SHAFT, 2.5" X 7.0" KELLY FIXED RETRACTOR, SQUARE SHAFT, 2" X 3" KELLY FIXED RETRACTOR, SQUARE SHAFT, 2" X 4" KELLY FIXED RETRACTOR, SQUARE SHAFT, 2" X 5" KELLY FIXED RETRACTOR, SQUARE SHAFT, 2" X 6" MALLEABLE FIXED RETRACTOR, SQUARE SHAFT, 1.5" X 6.0" MALLEABLE FIXED RETRACTOR, SQUARE SHAFT, 2.0" X 6.5" MALLEABLE FIXED RETRACTOR, SQUARE SHAFT, 3.0" X 6.5" Tilting Ratchet Clamp LARGE NATHANSON LIVER RETRACTOR MEDIUM NATHANSON LIVER RETRACTOR SMALL NATHANSON LIVER RETRACTOR Extra Small Oval Ring 6" x 7-3/4" Small Oval Ring 8 1/2"x 12" Small Round Ring 8 1/2" Large Round Ring 12 1/2" Small Segmented Ring Medium Segmented Ring Round Segmented Ring Standard Blade Clamp XXS Kelly Fixed Retractor, 2" x 1.5" XS Kelly Fixed Retractor, 2" x 2.5" Large Kelly Retractor 2" x 8" Large Deep Malleable Fixed Retractor, 3" x 8" Gelpi Retractor Child Kelly Retractor, 1" x 1-1/2" Child Kelly Retractor, 1" x 2-1/2" Tilting Ratchet Clamp Notched Malleable Fixed blade 2" x 6" Notched Malleable Fixed blade 2.5" x 6" Notched Malleable Fixed blade 2" x 8" 1 " DIA Vertical Extension Bar Speed-Tract Oval Split Frame Speed-Tract Round Split Frame Sterilization Container (for use with blades 11863-11868) Round Ring Frame with Double Arm Table Post (Double Joint) Handle Nut Washer, 3/4" (1.9cm), pkg 6 Swivel Blade Holder, 6" (15.2cm) Post, Table (Single Joint) Standard Crossbar with 3 Clamps Doherty-Harrington Retractor Blade Sternal Retractor, 3" x 3" (7.6cm x 7.6cm) Mayo Retractor, 2-3/4" x 2" (7cm x 5cm) Fence Swivel Blade, 4" x 6" (10.2cm x 15.2cm) Splanchnic Retractor, 2" x 6" (5cm x 15.2cm) Deaver Retractor, 4" x 5-1/2" (10.2cm x 14cm) Mayo Swivel Blade, 2-3/4" x 2" (7cm x 5cm) DEAVER RETRACTOR, 2-3/4" x 4-1/2" (7cm x 11.4cm) Mayo Swivel Blade, 3-1/2" x 2-3/4" (8.4cm x 7cm) RICHARDSON RETR AND ARM ASSY BLADE HOLDER ARM ASSY, MICRO ADJ Deaver Retractor, 1" 5" Deaver Retractor, 2" x 5" (5cm x 12.7cm) Splanchnic Swivel Blade, 2" x 4-1/2" Splanchnic Swivel Blade, 2" x 6" RICHARDSON SWIVEL RETRACTOR, 1 X 1 MINI LUNG RETRACTOR, 1-1/2" X 8" RAKE RETRACTOR, 7/8 X 1 CURVED MINI MAYO RETRACTOR, 2-3/4 X 2 MINI SPLANCHNIC RETRACTOR, 1-1/2 X 3-1/2 MINI Malleable Swivel Blade, 1-1/2" x 3" (3.8cm x 7.6cm) Malleable Swivel Blade, 1-1/2" x 4" (3.8cm x 10.2cm) MALLEABLE SWIVEL BLADE, 1-1/2 X 5 MALLEABLE SWIVEL BLADE, 1-1/2 X 6 BLADE HOLDER ARM ASSEMBLY, MINI MALLEABLE SWIVEL BLADE, 1 X 4 MALLEABLE SWIVEL BLADE, 1 X 5 MALLEABLE SWIVEL BLADE, 1 X 6 Harrington Sweetheart Retractor, 2" x 5" (5cm x 12.7cm) Harrington Sweetheart Retractor, 2" x 7" (7.6cm x 17.8cm) Pan/Cover Set (UA200) 12-1/2" x 26-1/2" x 3-5/8" (31.8cm x 6 Pan/Cover Set, 12-1/4" x 18-1/2" x 3-5/8" (31.1cm x 47cm x 9 Splanchnic Retractor, 2" x 8" (5cm x 20.3cm) Deaver Retractor, 2-3/4" x 8" (7cm x 20.3cm) Malleable Swivel Blade, 2" x 8" (5cm x 20.3cm) Fence Swivel Blade, 4" x 8" (12.7cm x 20.3cm) Mayo Swivel Retractor, 3-1/2" x 2-3/4" (8.9cm x 7cm) Marshall Prostate Swivel Blade, Malleable, 3"x6" (7.6cmx1) OMNI-CLAMP STERILE FIELD, 19-3/4" (50CM) ARM, ANGLED, 19" CIRCLE CLAMP, ONE PIECE, MINI WISHBONE, ADJUSTABLE ONE PIECE Circle Clamp, One Piece Hinged Extension Arm Richardson Stoney Retr 3/4" x 2-1/2" Micro Adjust Quick Clamp, One Piece Harrington Sweetheart Swivel Blade, 2" x 5" (5cm x 12.7cm) Harrington Sweetheart Swivel Blade, 2-1/2" x 7" (6.4cm x 17. Splanchnic Swivel Blade, 1-1/2" x 6" (3.8cm x 15.2cm) Splanchnic Swivel Blade, 1-1/2" x 4" (3.8cm x 10.2cm) MALLEABLE SWIVEL BLADE, 3/4 X 2 MALLEABLE SWIVEL BLADE, 3/4 X 3 CLAMP & BLOCK ASSEMBLY MAYO SWIVEL RETRACTOR, 1 X 1 MINI Malleable Swivel Retractor, 1 X 1 MINI Malleable Swivel Retractor, 1/2 X 1 MINI Mayo Swivel Retractor, 2 X 1-1/2 MINI Blade Holder with 3626 Knob, 9" (22.9cm) BLADE HOLDER, 6" 3379 HOLDER & 3626 KNOB Omni-Clamp Sterile Field Post, 15-3/4" (40cm) Lapo-Clamp (Scope Holder) 5mm/10mm Angled Arm, 7" x 16" (17.8 x 40.6cm) Flex Clamp Angled Side Arm, 8" x 18" (20.3cm x 45.7cm) KNOB, OMNI CLAMP MINI QUICK CLAMP Marshall Bladder Malleable Swivel Retractor, 3" x 6"(7.6cm x 15.2cm) DEAVER SWIVEL RETRACTOR, 1" x 3" MINI DEAVER SWIVEL RETRACTOR, 2" X 5" Fence Swivel Retractor, 4" x 8" (10.2cm x 20.3cm) POSTERIOR SWIVEL RETRACTOR, 1 3/4 X 3" POSTERIOR SWIVEL RETRACTOR 1 3/4 X 4" Mayo Swivel Retractor, 2-3/4" x 3" (7cm x 7.6cm) Malleable Swivel Retractor, 2" x 6-1/2" (5cm x 16.5cm) Malleable Swivel Retractor, 2" x 8" (5cm x 20.3cm) Malleable Swivel Retractor, 3" x 6-1/2" (7.6cm x 16.5cm) Malleable Swivel Retractor, 3" x 8" (7.6cm x 20.3cm) Malleable Swivel Retractor, 4" x 8" (10.2cm x 20.3cm) Splanchnic Swivel Retractor, 1-1/2" x 3-1/2 Instrument Holder Kelly Swivel Retractor, 2" x 3" (5cm x 7.6cm) Kelly Swivel Retractor, 2" x 4" (5cm x 10.2cm) Kelly Swivel Retractor, 2" x 5" (5cm x 12.7cm) Kelly Swivel Retractor, 2" x 6" (5cm x 15.2cm) Malleable Slotted Swivel Retractor, 1-1/2" x 6" (3.8cm x 15. Aluminum Renal Vein Swivel Ret 1" x 4-1/2" (2.5cm x 11.4cm) Aluminum Renal Vein Swivel Retract 1" x 4" (2.5cm x 10.2cm) SNAP CLAMP ASSEMBLY OMNI-RING, ROUND, 12-INCH WITH ARM FASTSYSTEM STERILE FIELD POST OMNI-RING, 12" X 18" OVAL Fence Finger Retractor, 2- 5/8" x 6" Renal Vein Swivel Retractor, 1" x 8" (2.5cm x 20.3cm) Hinged Cross Bar Standard Cross Bar Omni-Clamp Sterile Field Post Dbl Joint Clamp Assembly Stoney Richardson Rake Retractor,, 7/8" x 1" (2.2cm x 2.5cm) Rake Retractor, 7/8" x 1/2" (2.2cm x 1.3cm) Splanchnic Swivel Retractor, 1-1/2" x 3-1/2" (3.8cm x 8.9cm) Malleable Swivel Retractor, 1/2" x 1" (1.3cm x 2.5cm) Malleable Swivel Retractor, 3/4" x 2" (1.9cm x 5cm) Malleable Swivel Retractor, 3/4" x 3" (1.9cm x 7.6cm) Malleable Swivel Retractor, 1" x 1" (2.5cm x 2.5cm) Malleable Swivel Retractor, 1" x 4" (2.5cm x 10.2cm) Malleable Swivel Retractor, 1" x 5" (2.5cm x 12.7cm) Malleable Swivel Retractor, 1" x 6" (2.5cm x 15.2cm) Malleable Swivel Retractor, 1-1/2" x 3" (3.8cm x 7.6cm) Malleable Swivel Retractor, 1-1/2" x 4" (3.8cm x 10.2cm) Malleable Swivel Retractor, 1-1/2" x 5" (3.8cm x 12.7cm) Malleable Swivel Retractor, 1-1/2" x 6" (3.8cm x 15.2cm) Mayo Swivel Retractor, 1" x 1" (2.5cm x 2.5cm) Mayo Swivel Retractor, 2" x 1-1/2" (5cm x 3.8cm) Mayo Swivel Retractor, 2" x 2" (5cm x 5cm) Mayo Swivel Retractor, 2-3/4" x 2" (7cm x 5cm) FastSystem Small WISHBONE® Frame Extension Arm, 20" (51cm)
Model Identifier(s)
10244 10270 10272 10707 10708 10709 11050 11070 11119 11182 11183 11184 11275 11300R 11301R 11302R 11303R 11304R 11305R 11306 11308 11309 11321 11340 11352 11355 11360 11440 11441 11442 11443 11444 11445 11446 11447 11448 11480 11481 11482 11490 11510 11511 11512 11513 11514 11515 11516 11517 11518 11560 11627 11628 11629 11631 11632 11633 11634 11635 11636 11637 11638 11639 11640 11641 11642 11643 11644 11645 11646 11820 11821 11822 11826 11848 11849 11860 11861 3030R 3041R 3044 3046R 3055 3076 3091R 3094R 3096 3098 3099 3121R 3132R 3138R 3142 3167R 3177 3185 3187R 3218 3219 3225R 3265R 3281R 3336 3361R 3373R 3374R 3375R 3376R 3379R 3391 3392R 3393R 3398 3399R 3422R 3424 3529 3531 3532 3535 3536 3537 3555 3557 3565 3575 3586 3588 3594 3595 3596 3597 3601 3602 3603 3604 3610 3614 3616 3618 3620 3623 3624 3700 3720 3732 3740 3759 3761 3780 3792 3842 3848 3856R 3858R 3860 3866R 3872 3874 3876R 3878R 3882R 3886 3890 3906R 3907R 3908R 3909 3911 4017 4018R 4040 4070 4080 4090 4637 4929 4940 4943 4944 4954 4957 4958 4962 4963 4964 4965 4967 4968 4969 4970 4971 4972 4973 4974 4978 4979 4980 4981 4985 4988