| Primary Device ID | 10705034341804 |
| NIH Device Record Key | 3dcf4649-0edf-4f20-9095-49757d0c0a74 |
| Commercial Distribution Discontinuation | 2018-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | SPB500 |
| Catalog Number | SPB500 |
| 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 | 10705034341804 [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 |
| 10705034000442 - VSP | 2024-07-08 VSP SPINE SYSTEM CANNULATED SCREW CUTTER |
| 10705034000930 - ISOLA | 2024-07-08 ISOLA SPINE SYSTEM TRANSVERSE ROD CONNECTOR 6.35mm |
| 10705034004174 - NA | 2024-07-08 PLIG SYSTEM STRAIGHT DISC SPREADER 8mm |
| 10705034004181 - NA | 2024-07-08 PLIG SYSTEM STRAIGHT DISC SPREADER 10mm |
| 10705034004198 - NA | 2024-07-08 PLIG SYSTEM STRAIGHT DISC SPREADER 12mm |
| 10705034004204 - NA | 2024-07-08 PLIG SYSTEM STRAIGHT DISC SPREADER 14mm |
| 10705034007953 - PLIF | 2024-07-08 ADS PLIF BROACH SYSTEM FLAT RETRACTOR 13mm |
| 10705034011899 - ISOLA | 2024-07-08 ISOLA SPINE SYSTEM TANDEM CONNECTOR-4 SETSCREWS 6.35-6.35 x 50mm |