TANDEM 71324051
GUDID 03596010494429
TANDEM INTL BIPOLAR 51MM OD 28MM ID
Smith & Nephew, Inc.
Femoral head bipolar component| Primary Device ID | 03596010494429 |
| NIH Device Record Key | 927c6e12-56cc-42b6-b4cf-62fc7f07f06b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TANDEM |
| Version Model Number | 71324051 |
| Catalog Number | 71324051 |
| 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 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010494429 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023743
FDA Product Code
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| 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 |
Trademark Results [TANDEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANDEM 98713581 not registered Live/Pending |
Shawn Lioyryan 2024-08-23 |
 TANDEM 98664440 not registered Live/Pending |
SalesOps LLC 2024-07-24 |
 TANDEM 98641806 not registered Live/Pending |
AOG, LLC 2024-07-10 |
 TANDEM 98504318 not registered Live/Pending |
Volta Talent Strategies LLC 2024-04-17 |
 TANDEM 98427775 not registered Live/Pending |
TANDEM CYBER, LLC 2024-02-29 |
 TANDEM 98258222 not registered Live/Pending |
BioPharm Communications, LLC 2023-11-07 |
 TANDEM 98258202 not registered Live/Pending |
BioPharm Communications, LLC 2023-11-07 |
 TANDEM 98231582 not registered Live/Pending |
TANDEM INSTRUMENTS LLC 2023-10-19 |
 TANDEM 98094822 not registered Live/Pending |
Nigel Goonetilleke 2023-07-20 |
 TANDEM 98087650 not registered Live/Pending |
Red Scissor, Inc. 2023-07-17 |
 TANDEM 97917616 not registered Live/Pending |
Boehringer Ingelheim Animal Health USA Inc. 2023-05-02 |
 TANDEM 97843751 not registered Live/Pending |
TANDEM BUILDING PRODUCTS, LLC 2023-03-17 |
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