Tandem 126648

GUDID 03596010079770

TANDEM UNIPOLAR HEAD 48MM

Smith & Nephew, Inc.

Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis

• Primary Device ID: 03596010079770
• NIH Device Record Key: 506c3bfe-f430-453c-92ef-2a017fa50385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem
• Version Model Number: 126648
• Catalog Number: 126648
• Company DUNS: 109903521
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)821-5700
• 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
• 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
• 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	03596010079770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211176
• Premarket Notification: K896580

FDA Product Code

• LZY: Prosthesis, hip, hemi-, femoral, metal ball

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-08-25

On-Brand Devices [Tandem]

• 00885556028704: TANDEM TRIAL SHELL 55MM OD 26MM ID
• 00885556028100: TANDEM TRIAL SHELL 54MM OD 26MM ID
• 00885556027653: TANDEM TRIAL SHELL 53MM OD 26MM ID
• 00885556027578: TANDEM TRIAL SHELL 40MM OD 26MM ID
• 00885556027271: TANDEM TRIAL SHELL 39MM OD 26MM ID
• 00885556027066: TANDEM TRIAL SHELL 50MM OD 26MM ID
• 00885556026892: TANDEM TRIAL SHELL 45MM OD 26MM ID
• 00885556026854: TANDEM TRIAL SHELL 52MM OD 26MM ID
• 00885556026670: TANDEM TRIAL SHELL 44MM OD 26MM ID
• 00885556026588: TANDEM TRIAL SHELL 43MM OD 26MM ID
• 00885556026502: TANDEM TRIAL SHELL 49MM OD 26MM ID
• 00885556026441: TANDEM TRIAL SHELL 48MM OD 26MM ID
• 00885556026311: TANDEM TRIAL SHELL 47MM OD 26MM ID
• 00885556026267: TANDEM TRIAL HANDLE 26MM JAPAN
• 00885556026199: TANDEM TRIAL SHELL 42MM OD 26MM ID
• 00885556025970: TANDEM TRIAL HANDLE 22MM JAPAN
• 00885556025819: TANDEM TRIAL SHELL 46MM OD 26MM ID
• 00885556025086: TANDEM TRAY 26MM JAPAN
• 00885556020319: TANDEM BIPOLAR SHELL/XLPE LNR 49MM OD 22MM ID
• 00885556019962: TANDEM BIPOLAR SHELL/XLPE LNR 44MM OD 22MM ID
• 00885556019924: TANDEM BIPOLAR SHELL/XLPE LNR 48MM OD 22MM ID
• 00885556019627: TANDEM BIPOLAR SHELL/XLPE LNR 43MM OD 22MM ID
• 00885556019450: TANDEM BIPOLAR SHELL/XLPE LNR 38MM OD 22MM ID
• 00885556019399: TANDEM BIPOLAR SHELL/XLPE LNR 47MM OD 22MM ID
• 00885556019306: TANDEM BIPOLAR SHELL/XLPE LNR 42MM OD 22MM ID
• 00885556019139: TANDEM BIPOLAR SHELL/XLPE LNR 46MM OD 22MM ID
• 00885556018699: TANDEM BIPOLAR SHELL/XLPE LNR 50MM OD 22MM ID
• 03596010498243: TANDEM INTL BIPOLAR 59MM OD 28MM ID
• 03596010498236: TANDEM INTL BIPOLAR 57MM OD 28MM ID
• 03596010498229: TANDEM INTL BIPOLAR 39MM OD 22MM ID
• 03596010498212: TANDEM INTL BIPOLAR 38MM OD 22MM ID
• 03596010498144: TANDEM BIPOLAR COCR 39MM OD 22MM ID
• 03596010498137: TANDEM BIPOLAR COCR 38MM OD 22MMID
• 03596010497994: TANDEM STRAIGHT THREADED HANDLE
• 03596010494467: TANDEM INTL BIPOLAR 55MM OD 28MM ID
• 03596010494450: TANDEM INTL BIPOLAR 54MM OD 28MM ID
• 03596010494443: TANDEM INTL BIPOLAR 53MM OD 28MM ID
• 03596010494436: TANDEM INTL BIPOLAR 52MM OD 28MM ID
• 03596010494429: TANDEM INTL BIPOLAR 51MM OD 28MM ID
• 03596010494412: TANDEM INTL BIPOLAR 50MM OD 28MM ID
• 03596010494405: TANDEM INTL BIPOLAR 49MM OD 28MM ID
• 03596010494399: TANDEM INTL BIPOLAR 48MM OD 28MM ID
• 03596010494375: TANDEM INTL BIPOLAR 46MM OD 28MM ID
• 03596010494368: TANDEM INTL BIPOLAR 45MM OD 28MM ID
• 03596010494351: TANDEM INTL BIPOLAR 44MM OD 28MM ID
• 03596010494344: TANDEM INTL BIPOLAR 43MM OD 28MM ID
• 03596010494337: TANDEM INTL BIPOLAR 42MM OD 22MM ID
• 03596010494320: TANDEM INTL BIPOLAR 41MM OD 22MM ID
• 03596010494313: TANDEM INTL BIPOLAR 40MM OD 22MM ID
• 03596010492562: TANDEM BIPOLAR COCR 59MM OD 28MM ID