| Primary Device ID | 00857373006111 |
| NIH Device Record Key | 35223f38-11a9-4ff5-a0d8-e2d056967c5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ArchiMIS |
| Version Model Number | AD-1ch-4.0-120 |
| Catalog Number | AD-1ch-4.0-120 |
| 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 | false |
| 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 |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com | |
| Phone | 8606379922 |
| neil@avitusortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857373006111 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| 00857373006142 - Avitus ® Bone DebriderTM – Ø8mm, 255mm Shaft Length | 2024-07-16 Sterile, disposable surgical instrument with 8mm cutting tip for large volume debridement of cancellous bone, bio film and marro |
| 00857373006128 - DragonWing | 2023-09-05 Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system) |
| 00857373006111 - ArchiMIS | 2023-07-27Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system) |
| 00857373006111 - ArchiMIS | 2023-07-27 Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system) |
| 00857373006074 - Avitus Bone Harvester | 2020-10-16 Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow |
| 00857373006005 - Avitus Bone Harvester | 2018-07-06 A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting tip. The cap contains a barbed noz |
| 00857373006029 - Avitus Bone Harvester | 2018-07-06 Filter Accessory for REF: BH8 ONLY |
| 00857373006050 - Avitus Bone Harvester | 2018-07-06 A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting tip. The cap contains a barbed noz |
| 00857373006036 - Avitus Bone Harvester | 2018-03-29 A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting tip. The cap contains a barbed noz |