| Primary Device ID | 00885556905470 |
| NIH Device Record Key | 751cccf7-667c-4add-a45f-346cc04b674a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 74034197 |
| Catalog Number | 74034197 |
| Company DUNS | 045483575 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556905470 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
[00885556905470]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00885556905470 - NA | 2025-03-12VARIABLE ANGLE VALGUS GUIDE |
| 00885556905470 - NA | 2025-03-12 VARIABLE ANGLE VALGUS GUIDE |
| 00885556880876 - EVOS | 2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE |
| 00885556880883 - EVOS | 2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE |
| 00885556886403 - EVOS | 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL |
| 00885556886410 - EVOS | 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - LARGE |
| 23596010587682 - FOOTPRINT | 2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2 |
| 00885556905463 - NA | 2024-12-25 INSERT TRIAL PITCHFORK |
| 00885556915288 - NA | 2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT |