| Primary Device ID | 10705034341798 |
| NIH Device Record Key | 9770341f-fc74-4388-afe7-9ce0a2b0d3f5 |
| Commercial Distribution Discontinuation | 2018-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | SPB400 |
| Catalog Number | SPB400 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034341798 [Primary] |
| JEB | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-12-31 |
| 10705034576626 - N/A | 2025-01-20 MODIFIED INSTRUMENT PEDICLE AWL |
| 10705034577012 - N/A | 2025-01-20 MODIFIED INSTRUMENT SCREWDRIVER,STANDARD T25 |
| 10705034577029 - N/A | 2025-01-20 MODIFIED INSTRUMENT SCREWDRIVER,LONG T25 |
| 10705034577876 - N/A | 2024-12-27 MODIFIED INSTRUMENT BOX CUTTER 6mm x 4mm |
| 10705034577890 - N/A | 2024-12-27 MODIFIED INSTRUMENT POLY DRIVER T27 |
| 10705034576879 - N/A | 2024-12-13 MODIFIED INSTRUMENT STYLET 60mm |
| 10705034576923 - N/A | 2024-12-13 MODIFIED INSTRUMENT CURETTE 4mm |
| 10705034576930 - N/A | 2024-12-13 MODIFIED INSTRUMENT CURETTE 6mm |