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Integra™ Omni-Tract® Femur Elevator Retractor System - HSA Registration DE0014425

Access comprehensive regulatory information for Integra™ Omni-Tract® Femur Elevator 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 DE0014425 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
DE0014425
Integra™ Omni-Tract® Femur Elevator Retractor System
HSA Registration Number: DE0014425
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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
DE0014425
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)
Double-Tipped Hohman Blade Single-Tipped Hohman Blade` Double-Tipped PCL Blade Single-Tipped PCL Blade Rake, 2 cm Depth Rake, 4 cm Depth Rake, 6 cm Depth Z-Blade Cinch Frame Arm OmniAccess Knee Upper Organizer OmniAccess™ Pan and Cover OmniAccess™ Knee Lower Organizer SIDE SNAP CLAMP ASSEMBLY Ratchet Mechanism, Femur Elevator 9" Femur Hook  Sterile Field Post and Arm Swivel Blade Holder, 9" (22.9cm) Doherty Ghl Liver Blade, 4-1/4" x 3" (10.8cm x 7.6cm) Lechner-Harrington Liver Blade, 5" x 3-1/2" (12.7cm x 8.9cm) RICHARDSON SWIVEL RETRACTOR, 1 X 1 Richardson Swivel Retractor, 3/4" x 1-1/2" (1.9cm x 3.8cm) Richardson Swivel Retractor, 1" x 1-1/2" (2.5cm x 3.8cm) Finger Fence Swivel, 3-1/2" x 6" (8.9cm x 15.2cm) Kelly Modified Retractor, 3" x 3" (7.6cm x 7.6cm) Kelly Modified Retractor, 3" x 3-1/2" (7.6cm x 8.9cm) Kelly Modified Retractor, 3" x 4" (7.6cm x 10.2cm) Kelly Modified Retractor, 3" x 4-1/2" (7.6cm x 11.4cm) Malleable Swivel Blade, 2" x 6-1/2" (5cm x 16.5cm) Malleable Swivel Blade, 3" x 6-1/2" (7.6cm x 16.5cm) Malleable Swivel Blade, 4" x 6-1/2" BLADE HOLDER, 8" MICRO ADJ COMPLETE Splanchnic Retractor, 2" x 4-1/2" (5cm x 11.4cm) Richardson Swivel Retractor, 1-1/2" x 1-1/2" (3.8cm x 3.8cm) Deaver Swivel Blade, 2-3/4" x 4-1/2" (7cm x 11.4cm) Deaver Retractor, 1-1/2" x 6" (3.8cm x 15.2cm) Malleable Swivel Blade, 3" x 8" (7.6cm x 20.3cm) Malleable Swivel Blade, 4" x 8" Groin Swivel Retractor, 1-1/2" x 3-1/2" (3.8cm x 8.9cm) Malleable Slotted Swivel Blade, 2" x 6-1/2" (5cm x 16.5cm) Malleable Slotted Swivel Blade, 3" x 6-1/2" (7.6cm x 16.5cm) Blade Holder with 3626 Knob, 6" (15.2cm) Swivel Blade Holder Knob Splanchnic Swivel Retractor, 1-1/2" x 6" (3.8cm x 15.2cm) Kelly Modified Swivel Retractor, 3" x 2-1/2" (7.6cm x 6.4cm) Kelly Modified Swivel Retractor, 3" x 4" (7.6cm x 10.2cm) Mayo Swivel Retractor, 3-1/2" x 4" (8.4cm x 10.2cm) Malleable Swivel Retractor, 1-1/2" x 7" (3.8cm x 17.8cm) Malleable Swivel Retractor, 4" x 6-1/2" (10.2cm x 16.5cm) Fence Swivel Retractor, 4" x 5" (10.2cm x 12.7cm) Lapo-Clamp II ( Instrument Holder) Cloward Blade, 1/2" x 3" (1cm x 7.6cm) Cloward Tapered Blade, 3/4" x 1-1/4" (2cm x 3cm) Cloward Tapered Blade, 3/4" x 1-1/2" (2cm x 3.8cm) Lateral Blade (with lip), 3/4" x 2" (2cm x 5cm) Lateral Blade (with lip), 1" x 2" (2.5cm x 5cm) Lateral Blade (with lip), 1" x 3" (2.5cm x 7.6cm) Medial Blade (without lip), 1-1/4" x 2-3/4" (3cm x 7cm) Medial Blade (without lip), 1-1/2" x 2-3/4" (4cm x 7cm) Medial Blade (without lip), 1-1/2" x 3-1/2" (4cm x 8.9cm) Sub-Mandibular Malleable, 1" x 4" (2.5cm x 10.2cm) Sub-Mandibular Malleable, 1" x 6" (1cm x 15.2cm) Meyerding Blade (Blunt), 1" x 3" (2.5cm x 7.6cm) Meyerding Blade (Blunt), 2" x 2-1/2" (5cm x 6.4cm) Meyerding Blade (Blunt), 2" x 3" (5cm x 7.6cm) Richardson Blade, 3/4" x 2" (2cm x 5cm) Modified Meyerding (Right) Modified Meyerding (Left) Mayo Swivel Retractor, Aluminum, 2-3/4" x 2" (7cm x 5cm) Aluminum Mayo Swivel, Retractor, 3-1/2" x 2" (8.9cm x 5cm) Fence Swivel Retractor, Aluminum, 4" x 6" (10.2cm x 15.2cm) Splanchnic Swivel Retractor, Aluminum, 2" x 4-1/2" (5cm x 11 Splanchnic Swivel Retractor, Aluminum, 2" x 6" 5cm x 15.2cm Aluminum Deaver, Swivel Retractor, 2-3/4" x 4-1/2" Malleable Swivel Retractor, Aluminum, 2" x 6-1/2" (5cm x 16. Malleable Swivel Retractor, Aluminum, 3" x 6-1/2" (7.6cm x 1 Harrington Sweetheart Retractor, Aluminum, 2" x 5" (5 cm x 1 Splanchnic Swivel Retractor, Aluminum, 1-1/2" x 6" (3.8cm Splanchnic Swivel Retractor, Aluminum, 2" x 8" (5cm x 20.3cm Meyerding Blade, Radiolucent, 3/4" x 2" (2cm x 5cm) Meyerding Blade, Radiolucent, 1" x 2-1/2" (2.5cm x 6.4cm) Meyerding Blade, Radiolucent, 1" x 3" ( 2.5cm x 7.6cm) Meyerding Blade, Radiolucent, 2" x 2-1/2" (5cm x 6.4cm) Meyerding Blade, Radiolucent, 2" x 3" (5cm x 7.6cm) Meyerding Blade, Radiolucent, 2" x 4" (5cm x 10.2cm) Meyerding Blade, Radiolucent, 2" x 5" (5cm x 12.7cm) Double-Angled Blade, Radiolucent, 1" x 3" (2.5cm x 7.6cm) Universal Rail Clamp Mulier Blade, 1" x 2-1/2" (2.5cm x 6.4cm) Mulier Blade, 1" x 3-1/2" (2.5cm x 8.9cm) Mulier Blade, 1" x 4-1/2" (2.5cm x 11.4cm) Mulier Blade, 1" x 5-1/2" (2.5cm x 14cm) Mulier Blade, 2" x 2-1/2" (5cm x 6.4cm) Mulier Blade, 2" x 3-1/2" (5cm x 8.9cm) Mulier Blade, 2" x 4-1/2" (5cm x 11.4cm) Mulier Blade, 2" x 5-1/2" (5cm x 14cm) Meyerding Blade, 1" x 2-1/2" (2.5cm x 6.4cm) Meyerding Blade, 1" x 3-1/2" (2.5cm x 8.9cm) Meyerding Blade, 1" x 4-1/2" (2.5cm x 11.4cm) Meyerding Blade, 1" x 5-1/2" (2.5cm x 14cm) Meyerding Blade, 2" x 2-1/2" (5cm x 6.4cm) Meyerding Blade, 2" x 3-1/2" (5cm x 8.9cm) Meyerding Blade, 2" x 4-1/2" (5cm x 11.4cm) Meyerding Blade, 2" x 5-1/2" (5cm x 14cm) Bone Hook, 2-1/2" Bone Hook 4" (7.6cm) Bone Hook 5"(12.7cm) Arthro-Strap Blade Holder Richardson Swivel Retractor, 1" x 2" (2.5cm x 5cm) Anterior Swivel Retractor, 1-1/2" x 3"
Model Identifier(s)
10385 10386 10387 10388 10389 10390 10391 10405 10419 10487 10493 10498 11030 11500 11501 11502R 3069 3092 3093 3103R 3104R 3105R 3137 3145 3146 3147R 3148 3150R 3151R 3152R 3178R 3201 3220 3222 3274 3533 3534 3590 3592 3593 3622 3626 3800 3862 3864 3868R 3870 3880R 3892 3900 3914 3915 3916 3917 3918 3919 3921 3922 3923 3924 3925 3926 3927 3928 3929 3931 3932 3974 3975 3976 3977 3978 3980 3981 3982R 3983 4019 4105R 4400 4401 4402 4403 4404 4405 4406 4407 4547 4592 4593 4594 4595 4596 4597 4598 4599 4600 4601 4602 4603R 4604 4605 4606 4607 4615 4621 4622 4950 4961 4977