| Primary Device ID | 10705034245614 |
| NIH Device Record Key | 842a0983-1253-440e-8dea-72a95bf53698 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SPB100 |
| Catalog Number | SPB100 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034245614 [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 | 3 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-12-31 |
| 10705034003252 - ISOLA | 2024-04-05 ISOLA SPINE SYSTEM SPINAL WIRE WITH BUTTON 177.8mm |
| 10705034003269 - ISOLA | 2024-04-03 ISOLA SPINE SYSTEM DOUBLE WIRE 304.8mm |
| 10705034003276 - ISOLA | 2024-04-03 ISOLA SPINE SYSTEM BEADED WIRE 304.8mm |
| 10705034202952 - EXPEDIUM | 2024-04-03 EXPEDIUM SPINE SYSTEM WIRE CUTTER |
| 10705034302300 - EXPEDIUM | 2024-04-03 EXPEDIUM SPINE SYSTEM SMALL WIRE CUTTER |
| 10705034314716 - NA | 2024-04-03 MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm |
| 10705034484044 - NA | 2024-04-03 MODIFIED INSTRUMENT TREPHINE |
| 10705034492353 - NA | 2024-04-03 MODIFIED INSTRUMENT BONE HARVESTER |