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Integra Lifesciences Mayfield Cranial Stabilization System - HSA Registration DE0013790

Access comprehensive regulatory information for Integra Lifesciences Mayfield Cranial Stabilization 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 DE0013790 and owned by Integra LifeSciences Corporation. The device was registered on September 10, 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
DE0013790
Integra Lifesciences Mayfield Cranial Stabilization System
HSA Registration Number: DE0013790
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Product Description

Intended to be used for cranial stabilization and positioning to maintain the stability of a patient's head during brain surgery.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00105
HS Code
90189090
Registration Information
Registration Number
DE0013790
Registration Date
September 10, 2013
Change Notification Approval Date
December 17, 2018
Retention Due Date
September 09, 2025
Product Owner
Short Name
Integra LifeSciences Corporation
Address
4900 Charlemar Drive, Bldg A. Cincinnati,, Ohio 45227, UNITED STATES
Registrant
Address
1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model Information
Model Name(s)
XR2 CHILD ROCKER ASSEMBLY XR2 METAL FREE CONVERSION XR2 ACCESSORY-FORCE MODULE MAYFIELD GENERAL PURPOSE HEADREST Mayfield Swivel Horseshoe Headrest Mayfield Swivel Horseshoe Headrest Mayfield Crossbar Adaptor Mayfield Swivel Adaptor Mayfield Instrument Wall Storage Unit Mayfiled Reusable Adult Skull Pin Mayfield Reusable Child's Skull Pin Mayfield Pediatric Horseshoe Headrest Mayfield Modified Skull Clamp Mayfield Universal Side Rail Fitting Mayfield Ball Socket Swivel Adaptor Mayfield Disposable Adult Skull Pins - plastic Papadopolos P.C.S. Support Mayfield Radiolucent Base Unit with Adaptors Mayfield Disposable Adult Skull Pins - Steel Mayfield Disposable Child Skull Pins Mayfield Triad Skull Clamp Mayfield Horseshoe Conversion Adaptor Mayfield Horseshoe Conversion Adaptor with knobs Mayfield Radiolucent Tri-Star Swivel Adaptor Mayfield Infinity Support System Mayfield Neurogen Adaptor MAYFIELD INFINITY SKULL CLAMP Modified Swivel Adaptor Modified Tri-Star Adaptor Integra Cranial Stabilisation Covers Mayfield Titanium Disposable Adult and Child Skull Pins Mayfield Titanium Disposable Adult and Child Skull Pins Mayfield Titanium Reusable Adult and Child Skull Pins Mayfield Titanium Reusable Adult and Child Skull Pins Mayfield 2000 Skull Clamp Mayfield 2000 Radiolucent Skull Clamp Radiolucent 2000 Base System Mayfield Radiolucent Headrest System Mayfield Tri-Star Swivel Adaptor Ultra 360 Patient Positioning System Mayfield Adult Radiolucent Horseshoe Headrest Mayfield Pediatric Radiolucent Horseshoe Headrest Maygfield Radiolucent Disposable Skull Pin XR2 BASE UNIT ASSEMBLY Mayfield Ultra Base Unit XR2 TRI-STAR SWIVEL ADAPTOR MAYFIELD 2000 RADIOLUCENT SKULL CLAMP
Model Identifier(s)
439A1091 439A1092 439A1093 A1008 A1011 A1012 A1015 A1018 A1023 A1047 A1048 A1051 A1059 A1060 A1064 A1072 A1073 A1079 A1083 A1084 A1108 A1109 A1110 A1111 A1112 A1113 A1114 A1115 A1116 A1118 A1119 A1120 A1121 A1122 A2000 A2002 A2003 A2004 A2008 A2009 A2010 A2011 A2020 A2079 A2101 A2111 A2114