| Primary Device ID | 00857373006074 |
| NIH Device Record Key | dc1c13c5-482b-42c8-8918-c1cf2c8a14a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avitus Bone Harvester |
| Version Model Number | BH-220 |
| Catalog Number | BH-220 |
| Company DUNS | 078269403 |
| Company Name | AVITUS ORTHOPAEDICS, INC. |
| 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 | 00857373006074 [Primary] |
| KNW | Instrument, Biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-16 |
| Device Publish Date | 2020-10-08 |
| 00857373006050 | A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti |
| 00857373006036 | A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti |
| 00857373006029 | Filter Accessory for REF: BH8 ONLY |
| 00857373006005 | A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting ti |
| 00857373006074 | Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone a |