| Primary Device ID | B040ATR1 |
| NIH Device Record Key | 4fd58e03-c90d-4d6c-b24d-5be31d6f71c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVATR Minimally Invasive Adult Retractor with Interchangeable Blades |
| Version Model Number | ATR-1 |
| Catalog Number | ATR-1 |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com | |
| Phone | 800-786-4980 |
| contact@geneseebiomedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040ATR1 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
[B040ATR1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2024-08-28 |
| B040TF240 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF26 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF28 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF30 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF32 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF34 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF360 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF38 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |