| Primary Device ID | 00885556905463 |
| NIH Device Record Key | 3f1dc9a7-9b0e-48d9-999d-6e3018030e47 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 74034196 |
| Catalog Number | 74034196 |
| 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 | |
| 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 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556905463 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
[00885556905463]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-25 |
| Device Publish Date | 2024-12-17 |
| 00885556917794 - EVOS | 2025-12-31 EVOS 3.5MM X 54MM CORTEX SCREW SELF-TAPPING |
| 00885556915257 - NA | 2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT |
| 00885556915264 - NA | 2025-12-30 EM TIBIA ALIGNMENT TUBE MICRO SHORT |
| 00885556915271 - NA | 2025-12-30 MACRO EM TIBIA ALIGNMENT TUBE SHORT |
| 00885556915295 - NA | 2025-12-30 RM/LL TIBIA ALIGNMENT GUIDE SHORT |
| 00885556915301 - NA | 2025-12-30 TIBIA ALIGNMENT ADJUSTMENT GUIDE SHORT |
| 00885556915318 - NA | 2025-12-30 SYNC SHORT EXTRAMEDULLARY GUIDES MODULE |
| 00885556900260 - TRIGEN MAX | 2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI |