| Primary Device ID | 00885556829912 |
| NIH Device Record Key | d7780d3d-ac1e-4c14-88b5-2e941fe7ccda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Proximal Humeral Fracture Plate System |
| Version Model Number | HTG-0930-03R |
| Catalog Number | HTG-0930-03R |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556829912 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
[00885556829912]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| 00885556829912 | GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET |
| 00885556829899 | LOW PROFILE HUMERAL FRACTURE PLATE TARGET GUIDE. |
| 00885556829905 | GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET |
| 00885556829882 | LOW PROFILE HUMERAL FRACTURE PLATE TARGET GUIDE. |
| 00885556829929 | 1.9MM LOCKING DRILL GUIDE |
| 00885556830406 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 75MM |
| 00885556830390 | 3.5MM LOCKING SCREW STAINLESS STEEL 75MM |
| 00885556830383 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 70MM |
| 00885556830376 | 3.5MM LOCKING SCREW STAINLESS STEEL 70MM |
| 00885556830369 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 65MM |
| 00885556830352 | 3.5MM LOCKING SCREW STAINLESS STEEL 65MM |
| 00885556830345 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 60MM |
| 00885556830338 | 3.5MM LOCKING SCREW STAINLESS STEEL 60MM |
| 00885556830321 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 55MM |
| 00885556830314 | 3.5MM LOCKING SCREW STAINLESS STEEL 55MM |
| 00885556830307 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 50MM |
| 00885556830291 | 3.5MM LOCKING SCREW STAINLESS STEEL 50MM |
| 00885556830284 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 45MM |
| 00885556830277 | 3.5MM LOCKING SCREW STAINLESS STEEL 45MM |
| 00885556830260 | 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 40MM |
| 00885556830253 | 3.5MM LOCKING SCREW STAINLESS STEEL 40MM |
| 00885556830246 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 40MM |
| 00885556830239 | 3.5MM LOCKING SCREW STAINLESS STEEL 37.5MM |
| 00885556830222 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 37.5MM |
| 00885556830215 | 3.5MM LOCKING SCREW STAINLESS STEEL 35MM |
| 00885556830208 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 35MM |
| 00885556830192 | 3.5MM LOCKING SCREW STAINLESS STEEL 32.5MM |
| 00885556830185 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 32.5MM |
| 00885556830178 | 3.5MM LOCKING SCREW STAINLESS STEEL 30MM |
| 00885556830161 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 30MM |
| 00885556830154 | 3.5MM LOCKING SCREW STAINLESS STEEL 27.5MM |
| 00885556830147 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 27.5MM |
| 00885556830130 | 3.5MM LOCKING SCREW STAINLESS STEEL 25MM |
| 00885556830123 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 25MM |
| 00885556830116 | 3.5MM LOCKING SCREW STAINLESS STEEL 22.5MM |
| 00885556830109 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 22.5MM |
| 00885556830093 | 3.5MM LOCKING SCREW STAINLESS STEEL 20MM |
| 00885556830086 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 20MM |
| 00885556830079 | 3.5MM LOCKING SCREW STAINLESS STEEL 17.5MM |
| 00885556830062 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 17.5MM |
| 00885556830055 | 3.5MM LOCKING SCREW STAINLESS STEEL 15MM |
| 00885556830048 | 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 15MM |
| 00885556830031 | 2.7MM LOCKING SCREW SS 25MM |
| 00885556830024 | 2.7MM LOCKING SCREW SS 22.5MM |
| 00885556830017 | 2.7MM LOCKING SCREW SS 20MM |
| 00885556830000 | 2.7MM LOCKING SCREW SS 17.5MM |
| 00885556829998 | 2.7MM LOCKING SCREW SS 15MM |
| 00885556829981 | 2.7MM LOCKING SCREW SS 12.5MM |
| 00885556829974 | 2.7MM LOCKING SCREW SS 10MM |
| 00885556829875 | GREATER TUBEROSITY HUMERAL FRACTURE PLATE 10-HOLE. RIGHT |