| Primary Device ID | 00840996160308 |
| NIH Device Record Key | aacc2a54-33f9-4cfd-bfe6-7ef51f44e6da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SILVERBOLT 2 PEDICLE SCREW SYSTEM |
| Version Model Number | BSK-8703 |
| Company DUNS | 078293017 |
| Company Name | Choice Spine, LP |
| 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 | true |
| 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(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840996160308 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840996160308]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-26 |
| 00840996160308 | SBOLT,TORQ HANDLE SQ DRV, 60 INLB |
| 00840996187381 | SILVERBOLT,GUIDEWIRES,BLUNT,NONSTERILE |
| 00840996187374 | SILVERBOLT,GUIDEWIRES,NONSTERILE |