| Primary Device ID | M224BRS54749 |
| NIH Device Record Key | d9e03c19-3adb-4628-8859-064174286572 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inion BioRestore™ Sahara |
| Version Model Number | 1 |
| Catalog Number | BRS-5474 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M224BRS54749 [Primary] |
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-04 |
| Device Publish Date | 2018-11-22 |
| M224BRS54749 | Oval, Standard 8 mm |
| 06438408009587 | Block, Large, Wedge 14 mm |
| 06438408009570 | Block, Large, Wedge 12 mm |
| 06438408009563 | Block, Large, Wedge 10 mm |
| 06438408009556 | Block, Large, Wedge 8 mm |
| 06438408009549 | Block, Large 14 mm |
| 06438408009532 | Block, Large 12 mm |
| 06438408009525 | Block, Large 10 mm |
| 06438408009518 | Block, Large 8 mm |
| 06438408009501 | Block, Standard, Wedge 14 mm |
| 06438408009495 | Block, Standard, Wedge 12 mm |
| 06438408009488 | Block, Standard, Wedge 10 mm |
| 06438408009471 | Block, Standard, Wedge 8 mm |
| 06438408009464 | Block, Standard 14 mm |
| 06438408009419 | Oval, Standard 7 mm |
| 06438408009402 | Oval, Standard 6 mm |
| 06438408009396 | Oval, Standard 5 mm |
| 06438408009389 | Oval, Standard 4 mm |
| 06438408009372 | Oval, Small 8 mm |
| 06438408009365 | Oval, Small 7 mm |
| 06438408009358 | Oval, Small 6 mm |
| 06438408009341 | Oval, Small 5 mm |
| 06438408009044 | Block, Standard 12 mm |
| 06438408009037 | Block, Standard 10 mm |
| 06438408009020 | Block, Standard 8 mm |
| 06438408009426 | Oval, Standard 8 mm |