BIRMINGHAM HIPTM RESURFACING 901238

GUDID 03596010503428

BHR SLEEVE RING SZ 38

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit
Primary Device ID03596010503428
NIH Device Record Keyc2a521c6-0969-42de-a62e-5f242f4adf41
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIRMINGHAM HIPTM RESURFACING
Version Model Number901238
Catalog Number901238
Company DUNS045483575
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010503428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXTProsthesis, hip, semi-constrained, metal/metal, resurfacing

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


[03596010503428]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-07
Device Publish Date2015-11-25

On-Brand Devices [BIRMINGHAM HIPTM RESURFACING]

00885556075319BHR TRIAL HEAD KIT
03596010503077MODULAR HEAD 46 MM -8MM
03596010503039MODULAR HEAD 42 MM -8MM
03596010533777BHR INSTRUMENT TRAY 4
03596010533760BIRMINGHAM HIP INSTRUMENT TRAY 3
03596010533753BIRMINGHAM HIP INSTRUMENT TRAY 2
03596010533746BIRMINGHAM HIP INSTRUMENT TRAY 1
03596010503541BHR HEAD CENTRE CHECK JIG SZ 58
03596010503527BHR HEAD CENTRE CHECK JIG SZ 54
03596010503510BHR HEAD CENTRE CHECK JIG SZ 46
03596010503503BHR HEAD CENTRE CHECK JIG SZ 42
03596010503497BHR HEAD CENTRE CHECK JIG SZ 38
03596010503480BHR CHECK JIG MAIN BODY
03596010503459BHR SLEEVE RING SIZE 50
03596010503442BHR SLEEVE RING SZ 46
03596010503435BHR SLEEVE RING SZ 42
03596010503428BHR SLEEVE RING SZ 38

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