| Primary Device ID | 10705034395173 |
| NIH Device Record Key | 6fa5bba0-c130-4fae-b5d1-e17f53afc5f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 698335798 |
| Catalog Number | 698335798 |
| 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 | |
| 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 | 10705034395173 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-27 |
| Device Publish Date | 2023-11-17 |
| 10705034543055 - N/A | 2024-09-11 MODIFIED INSTRUMENT DOWN-BITING CUP CURETTE 4mm |
| 10705034546995 - N/A | 2024-09-11 MODIFIED INSTRUMENT INSERTER, STRAIGHT |
| 10705034547640 - N/A | 2024-09-11 MODIFIED INSTRUMENT FINAL TIGHTENER X25 |
| 10705034547695 - N/A | 2024-09-11 MODIFIED INSTRUMENT FACILITATOR |
| 10705034547862 - N/A | 2024-09-11 MODIFIED INSTRUMENT FACILITATOR, SHORT TAB |
| 10705034491202 - NA | 2024-08-20 MODIFIED INSTRUMENT GRAFT PUSHER |
| 10705034575964 - N/A | 2024-08-12 MODIFIED INSTRUMENT DRIVER X 25 |
| 10705034576787 - N/A | 2024-08-12 MODIFIED INSTRUMENT BLADE HOLDER HANDLE |