| Primary Device ID | H6793949930 |
| NIH Device Record Key | bd8d524c-1064-452a-9919-d9d695c126ee |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 394.993 |
| Catalog Number | 394993 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20886982200065 [Primary] |
| GS1 | 80886982200067 [Unit of Use] |
| HIBCC | H6793949930 [Secondary] |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
[H6793949930]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-14 |
| 10886982297280 - NA | 2024-09-11 SCHANZ PIN REMOVAL TOOL |
| H9814871830 - Click'X | 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH |
| H9812982060 - NA | 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE |
| H6792042280 - NA | 2024-07-24 3.5MM SHAFT SCREW 28MM |
| H6792042320 - NA | 2024-07-24 3.5MM SHAFT SCREW 32MM |
| H6792042340 - NA | 2024-07-24 3.5MM SHAFT SCREW 34MM |
| H6792042360 - NA | 2024-07-24 3.5MM SHAFT SCREW 36MM |
| H6792042380 - NA | 2024-07-24 3.5MM SHAFT SCREW 38MM |