Tandem 71326604

GUDID 03596010196569

TANDEM UNIPOLAR 12/14 TAPER SLEEVE +4

Smith & Nephew, Inc.

Metallic femoral head prosthesis

• Primary Device ID: 03596010196569
• NIH Device Record Key: 5f32cc08-a18a-47c6-84d5-191efdc65034
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem
• Version Model Number: 71326604
• Catalog Number: 71326604
• 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	03596010196569 [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: 2015-08-30

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