BIRMINGHAM HIPTM RESURFACING 901246

GUDID 03596010503442

BHR SLEEVE RING SZ 46

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03596010503442
• NIH Device Record Key: 5a6d9db9-ac34-455f-912e-628f8b33f712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIRMINGHAM HIPTM RESURFACING
• Version Model Number: 901246
• Catalog Number: 901246
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010503442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040033

FDA Product Code

• NXT: Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

[03596010503442]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-11-25

On-Brand Devices [BIRMINGHAM HIPTM RESURFACING]

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