| Primary Device ID | 00885556835036 |
| NIH Device Record Key | cc5c5ed8-6881-449b-b972-4a3e2ee228de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ti6 Internal Fixation System |
| Version Model Number | DS1008 |
| Catalog Number | DS1008 |
| 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 | 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 | |
| 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 | 00885556835036 [Primary] |
| HTJ | GAUGE, DEPTH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
[00885556835036]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00885556835227 | BONE REDUCTION FORCEPS SERRATED |
| 00885556835210 | BONE REDUCTION FORCEPS SWEETHEART STYLE |
| 00885556835500 | TQSERIES QUICKSNAP 3PRONG DRIVER SHAFT |
| 00885556835494 | THSERIES REMOVAL DRIVER SHAFT |
| 00885556835470 | THSERIES CANN. DEPTH GAUGE |
| 00885556835463 | THSERIES CANN. DRIVER SHAFT |
| 00885556835432 | TCSERIES CANN. DEPTH GAUGE/CSINK. 3.0/4.0MM SCREWS |
| 00885556835425 | TCSERIES CANN. DEPTH GAUGE/CSINK. 2.0/2.5MM SCREWS |
| 00885556835418 | TCSERIES 3.0 / 4.0MM CANNULATED DRIVER SHAFT |
| 00885556835401 | TCSERIES 2.0 / 2.5MM CANNULATED DRIVER SHAFT |
| 00885556835395 | TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS - AO |
| 00885556835388 | TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS |
| 00885556835371 | TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS - AO |
| 00885556835364 | TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS |
| 00885556835357 | TSSERIES DRILL GUIDE FOR 3.0 & 4.0MM SCREWS |
| 00885556835340 | TSSERIES DRILL GUIDE FOR 2.0 & 2.5MM SCREWS |
| 00885556835319 | TSSERIES 3.0 / 4.0MM DRIVER SHAFT |
| 00885556835302 | TSSERIES 2.0 / 2.5MM DRIVER SHAFT |
| 00885556835258 | SCREW REMOVAL TOOL |
| 00885556835241 | SCREW PICKUP FORCEPS |
| 00885556835234 | BONE REDUCTION FORCEPS SCARF |
| 00885556835197 | TITANIUM SWIVEL DRIVER HANDLE |
| 00885556835180 | TI6 DIGITAL FUSION DRIVER SHAFT |
| 00885556835036 | TI6 DIGITAL SCREW COUNTERSINKDEPTH GAUGE |
| 00885556836156 | TI6 HEADLESS 2.5MM X 22MM BONE SCREW |
| 00885556836149 | TI6 HEADLESS 2.5MM X 20MM BONE SCREW |
| 00885556836132 | TI6 HEADLESS 2.5MM X 18MM BONE SCREW |
| 00885556836125 | TI6 HEADLESS 2.5MM X 16MM BONE SCREW |
| 00885556836118 | TI6 HEADLESS 2.5MM X 14MM BONE SCREW |
| 00885556836101 | TI6 HEADLESS 2.5MM X 12MM BONE SCREW |
| 00885556836095 | TI6 HEADLESS 2.5MM X 10MM BONE SCREW |
| 00885556836088 | TI6 LOW PROFILE 4.0MM X 50MM BONE SCREW |
| 00885556836071 | TI6 LOW PROFILE 4.0MM X 46MM BONE SCREW |
| 00885556836064 | TI6 LOW PROFILE 4.0MM X 42MM BONE SCREW |
| 00885556836057 | TI6 LOW PROFILE 4.0MM X 40MM BONE SCREW |
| 00885556836040 | TI6 LOW PROFILE 4.0MM X 38MM BONE SCREW |
| 00885556836033 | TI6 LOW PROFILE 4.0MM X 36MM BONE SCREW |
| 00885556836026 | TI6 LOW PROFILE 4.0MM X 34MM BONE SCREW |
| 00885556836019 | TI6 LOW PROFILE 4.0MM X 32MM BONE SCREW |
| 00885556836002 | TI6 LOW PROFILE 4.0MM X 30MM BONE SCREW |
| 00885556835999 | TI6 LOW PROFILE 4.0MM X 28MM BONE SCREW |
| 00885556835982 | TI6 LOW PROFILE 4.0MM X 26MM BONE SCREW |
| 00885556835975 | TI6 LOW PROFILE 4.0MM X 24MM BONE SCREW |
| 00885556835968 | TI6 LOW PROFILE 4.0MM X 22MM BONE SCREW |
| 00885556835951 | TI6 LOW PROFILE 4.0MM X 20MM BONE SCREW |
| 00885556835944 | TI6 LOW PROFILE 4.0MM X 18MM BONE SCREW |
| 00885556835937 | TI6 LOW PROFILE 4.0MM X 16MM BONE SCREW |
| 00885556835913 | TI6 LOW PROFILE 4.0MM X 12MM BONE SCREW |
| 00885556835890 | TI6 LOW PROFILE 3.0MM X 36MM BONE SCREW |
| 00885556835883 | TI6 LOW PROFILE 3.0MM X 34MM BONE SCREW |