| Primary Device ID | 00885556839843 |
| NIH Device Record Key | 774d9887-c1ca-49da-bac8-6187739b0413 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Total Foot System 2 |
| Version Model Number | PBH-800-01 |
| Catalog Number | PBH-800-01 |
| 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 | 00885556839843 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
Moist Heat or Steam Sterilization
[00885556839843]
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 |
| 00885556839935 | TX 8 DRIVER. NON-CANNULATED W/AO |
| 00885556839881 | MODIFIED MINI JANSEN RETRACTORS |
| 00885556839867 | MPJ 1.8MM INTERFRAG DRILL GUIDE RIGHT |
| 00885556839850 | REARFOOT DISTRACTION GAUGE |
| 00885556839843 | TFS PLATE BENDER HANDLE ASSY. SMALL |
| 00885556839836 | TFS PLATE BENDER HANDLE ASSY. LARGE |
| 00885556839829 | MPJ 1.8MM INTERFRAG DRILL GUIDE LEFT |
| 00885556839812 | 2.5MM LOCKING DRILL GUIDE (YELLOW) |
| 00885556839799 | K-WIRE DISTRACTION/COMPRESSION FORCEPS |
| 00885556839782 | 2.5MM HEX DRIVER. NON-CANNULATED W/AO |
| 00885556839775 | FOREFOOT DISTRACTION GAUGE |
| 00885556837849 | DOUBLE DRILL GUIDE HANDLE |
| 00885556828106 | PLATE BENDING IRON |
| 00885556828069 | CUP & CONE CADDY LID |
| 00885556828052 | CONE SPHERICAL REAMER SZ. 24MM |
| 00885556828045 | CONE SPHERICAL REAMER SZ. 21MM |
| 00885556828038 | CONE SPHERICAL REAMER SZ. 19MM |
| 00885556828021 | CONE SPHERICAL REAMER SZ. 16MM |
| 00885556828014 | CUP SPHERICAL REAMER SZ. 24MM |
| 00885556828007 | CUP SPHERICAL REAMER SZ. 21MM |
| 00885556827994 | CUP SPHERICAL REAMER SZ. 19MM |
| 00885556827987 | CUP SPHERICAL REAMER SZ. 16MM |
| 00885556838990 | OPEN WEDGE PLATE STEM SZ. 6MM |
| 00885556838983 | OPEN WEDGE PLATE STEM SZ. 5MM |
| 00885556838976 | OPEN WEDGE PLATE STEM SZ. 4MM |
| 00885556838969 | OPEN WEDGE PLATE STEM SZ. 3MM |
| 00885556838952 | OPEN WEDGE PLATE STEM SZ. 2MM |
| 00885556838945 | OPEN WEDGE PLATE STEM SZ. 0MM |
| 00885556838327 | TARSALIS PLATE 10 HOLE STRAIGHT |
| 00885556838310 | TARSALIS PLATE 3 HOLE STRAIGHT LONG |
| 00885556838297 | TARSALIS PLATE 2 HOLE STRAIGHT SHORT |
| 00885556838259 | MPJ FUSION PLATE LONG RIGHT |
| 00885556838228 | MPJ FUSION PLATE MEDIUM LEFT |
| 00885556838211 | CALCANEUS PLATE SZ. MINI-LONG |
| 00885556838303 | TARSALIS PLATE 2 HOLE STRAIGHT LONG |
| 00885556838242 | MPJ FUSION PLATE LONG LEFT |
| 00885556838235 | MPJ FUSION PLATE MEDIUM RIGHT |
| 00885556838204 | CALCANEUS PLATE SZ. MINI |
| 00885556837870 | OLIVE WIRE 1.1MM DIA. X 100MM |
| 00885556837993 | FOREFOOT UNIVERSAL PLATE. 18MM |
| 00885556837986 | FOREFOOT UNIVERSAL PLATE. 16MM |
| 00885556837979 | FOREFOOT UNIVERSAL PLATE. 14MM |
| 00885556839027 | OPEN WEDGE PLATE. 4.5MM |
| 00885556839010 | OPEN WEDGE PLATE. 3.5MM |
| 00885556839003 | OPEN WEDGE PLATE. 2.5MM |
| 00885556838433 | TARSALIS PLATE. 8-HOLE T SHAPE RIGHT |
| 00885556838426 | TARSALIS PLATE. 7-HOLE T SHAPE RIGHT |
| 00885556838419 | TARSALIS PLATE. 6-HOLE T SHAPE STRAIGHT |
| 00885556838396 | TARSALIS PLATE. 4-HOLE STRAIGHT |
| 00885556838341 | TARSALIS PLATE. 4-HOLE T SHAPE STRAIGHT |