| Primary Device ID | H981036611060 |
| NIH Device Record Key | f396c5ee-d615-4fdc-bab1-74788430f2f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANTEGRA-T |
| Version Model Number | 03.661.106 |
| Catalog Number | 03661106 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034721132 [Primary] |
| HIBCC | H981036611060 [Secondary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
[H981036611060]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-04-26 |
| Device Publish Date | 2016-12-31 |
| H98104103053S0 | TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL |
| H98104103051S0 | TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-SACRAL |
| H98104103049S0 | TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-SACRAL |
| H98104103047S0 | TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-SACRAL |
| H98104103045S0 | TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-SACRAL |
| H98104103043S0 | TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-SACRAL |
| H98104103041S0 | TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-SACRAL |
| H98104103039S0 | TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-SACRAL |
| H98104103037S0 | TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-SACRAL |
| H98104102053S0 | TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-LUMBAR |
| H98104102051S0 | TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-LUMBAR |
| H98104102049S0 | TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-LUMBAR |
| H98104102047S0 | TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-LUMBAR |
| H98104102045S0 | TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-LUMBAR |
| H98104102043S0 | TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-LUMBAR |
| H98104102041S0 | TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-LUMBAR |
| H98104102039S0 | TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-LUMBAR |
| H98104102037S0 | TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-LUMBAR |
| H981036611390 | TRIAL ANTEGRA-T PLATE LUMBAR/53MM |
| H981036611380 | TRIAL ANTEGRA-T PLATE LUMBAR/51MM |
| H981036611370 | TRIAL ANTEGRA-T PLATE LUMBAR/49MM |
| H981036611360 | TRIAL ANTEGRA-T PLATE LUMBAR/47MM |
| H981036611350 | TRIAL ANTEGRA-T PLATE LUMBAR/45MM |
| H981036611340 | TRIAL ANTEGRA-T PLATE LUMBAR/43MM |
| H981036611330 | TRIAL ANTEGRA-T PLATE LUMBAR/41MM |
| H981036611320 | TRIAL ANTEGRA-T PLATE LUMBAR/39MM |
| H981036611310 | TRIAL ANTEGRA-T PLATE LUMBAR/37MM |
| H981036611090 | TRIAL ANTEGRA-T PLATE SACRAL/53MM |
| H981036611080 | TRIAL ANTEGRA-T PLATE SACRAL/51MM |
| H981036611070 | TRIAL ANTEGRA-T PLATE SACRAL/49MM |
| H981036611060 | TRIAL ANTEGRA-T PLATE SACRAL/47MM |
| H981036611050 | TRIAL ANTEGRA-T PLATE SACRAL/45MM |
| H981036611040 | TRIAL ANTEGRA-T PLATE SACRAL/43MM |
| H981036611030 | TRIAL ANTEGRA-T PLATE SACRAL/41MM |
| H981036611020 | TRIAL ANTEGRA-T PLATE SACRAL/39MM |
| H981036611010 | TRIAL ANTEGRA-T PLATE SACRAL/37MM |
| H981SD036611250 | ANTEGRA-T TEMPORARY FIXATION PIN-EXTRA LONG |
| H981SD031610530 | ANTEGRA-T AWL-EXTRA LONG |