BIRMINGHAM HIP RESURFACING(BHR) 90035585

GUDID 03596010606266

REMOVAL TOOL

Smith & Nephew, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device ID03596010606266
NIH Device Record Key9736efd6-8349-412d-81ae-169f646592f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIRMINGHAM HIP RESURFACING(BHR)
Version Model Number90035585
Catalog Number90035585
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010606266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


[03596010606266]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2017-11-13

On-Brand Devices [BIRMINGHAM HIP RESURFACING(BHR)]

03596010606266REMOVAL TOOL
03596010565921MODULAR HEAD SEPARATION DEVICE
03596010606259MODULAR SNAP FIT TRIAL NECK +8
03596010606242MODULAR SNAP FIT TRIAL NECK +4
03596010606235MODULAR SNAP FIT TRIAL NECK 0
03596010606228MODULAR SNAP FIT TRIAL NECK -4
03596010578617MODULAR HEAD TRIAL 58MM
03596010578600MODULAR HEAD TRIAL 54MM
03596010578594MODULAR HEAD TRIAL 50MM
03596010578587MODULAR HEAD TRIAL 46MM
03596010578570MODULAR HEAD TRIAL 42MM
03596010578563MODULAR HEAD TRIAL 38MM
03596010565938MODULAR SLEEVE REMOVER
03596010565860MODULAR HEAD TRIAL 56MM
03596010565853MODULAR HEAD TRIAL 52MM
03596010565846MODULAR HEAD TRIAL 48MM
03596010565839MODULAR HEAD TRIAL 44MM
03596010565822MODULAR HEAD TRIAL 40MM

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