| Primary Device ID | 00885554008258 |
| NIH Device Record Key | 7a6c27a2-b23e-4c81-b63e-76e4499273c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUHL/ACUFEX |
| Version Model Number | 6905009 |
| Catalog Number | 6905009 |
| Company DUNS | 109903521 |
| 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 | false |
| OTC Over-The-Counter | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00885554008258 [Primary] |
| KQZ | COMPONENT, TRACTION, NON-INVASIVE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
[00885554008258]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-04-12 |
| 00885556919323 - Journey II | 2024-05-31 ANKLE CLAMP |
| 00885556919309 - Trigen | 2024-05-30 3.2MM X 343MM SMOOTH ENDED DRILL TIP PIN |
| 00885556887165 - PLATINUM | 2024-05-27 PLATINUM MDU BF |
| 00885556919033 - R3 | 2024-05-24 R3 ANTI-ROTATION TIP W/FLAT SZ58MM |
| 00885556918616 - R3 | 2024-05-23 SHORT OFFSET ACETABULAR IMPACTOR |
| 00885556918623 - R3 | 2024-05-23 SZ 42MM BRIDGEBACK REAMER |
| 00885556918630 - R3 | 2024-05-23 SZ 44MM BRIDGEBACK REAMER |
| 00885556918647 - R3 | 2024-05-23 SZ 46MM BRIDGEBACK REAMER |