| Primary Device ID | 06438408009334 |
| NIH Device Record Key | cecbc939-83e8-4ec0-8693-55755ac9baad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inion BioRestore™ |
| Version Model Number | 1 |
| Catalog Number | BRS-5460 |
| 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 |
|---|---|
| GS1 | 06438408009334 [Primary] |
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
| M224BRS54609 | Oval, small 4 mm |
| M224BRS54319 | Morsels 4.5 cc |
| M224BRS54309 | Morsels 1.5 cc |
| M224BRS54139 | Oval 7 mm |
| 06438408009327 | Cylinder 8 x 15 mm |
| 06438408009310 | Block 60 x 40 x 8 mm |
| 06438408009303 | Block 30 x 20 x 8 mm |
| 06438408009297 | Block 15 x 25 x 4 mm |
| 06438408009280 | Block 5 x 10 x 4 mm |
| 06438408009273 | Block, Wedge 13 mm |
| 06438408009266 | Block, Wedge 4 mm |
| 06438408009259 | Block, Gradient 13 mm |
| 06438408009242 | Block, Gradient 4 mm |
| 06438408009013 | Oval 13 mm |
| 06438408009006 | Oval 9 mm |
| 06438408008993 | Oval 8 mm |
| 06438408008979 | Oval 6 mm |
| 06438408008962 | Oval 5 mm |
| 06438408008955 | Oval 4 mm |
| 06438408009334 | Oval, small 4 mm |
| 06438408008986 | Oval 7 mm |
| 06438408003097 | Morsels 4.5 cc |
| 06438408003080 | Morsels 1.5 cc |