| Primary Device ID | 10705034484044 |
| NIH Device Record Key | 39a80ad0-15ed-4143-9bc5-4b73186cbbe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 698341827 |
| Catalog Number | 698341827 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034484044 [Primary] |
| HWK | TREPHINE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
[10705034484044]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-04-03 |
| Device Publish Date | 2016-11-11 |
| 10705034575124 - N/A | 2024-09-20 MODIFIED INSTRUMENT POWER POLY DRIVER |
| 10705034576428 - N/A | 2024-09-20 MODIFIED INSTRUMENT TAP |
| 10705034576473 - N/A | 2024-09-20 MODIFIED INSTRUMENT TAP |
| 10705034576480 - N/A | 2024-09-20 MODIFIED INSTRUMENT DRIVER |
| 10705034576534 - N/A | 2024-09-20 MODIFIED INSTRUMENT TAP |
| 10705034576633 - N/A | 2024-09-19 MODIFIED INSTRUMENT OSTEOTOME |
| 10705034576657 - N/A | 2024-09-19 MODIFIED INSTRUMENT DISTRACTOR LEG, SHORT |
| 10705034576688 - N/A | 2024-09-19 MODIFIED INSTRUMENT ACDF SHIM |