| Primary Device ID | B040FRN38 |
| NIH Device Record Key | 855962f8-62d9-43c3-bac0-432c074fd1ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexForm Annuloplasty Ring |
| Version Model Number | FRN-38 |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040FRN38 [Package] Contains: B040FRN3803 Package: [1 Units] In Commercial Distribution |
| HIBCC | B040FRN3803 [Primary] |
| KRH | Ring, Annuloplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-01 |
| B040FRN40 | Annuloplasty Ring |
| B040FRN38 | Annuloplasty Ring |
| B040FRN36 | Annuloplasty Ring |
| B0040FRN34 | Annuloplasty Ring |
| B040FRN32 | Annuloplasty Ring |
| B040FRN30 | Annuloplasty Ring |
| B040FRN28 | Annuloplasty Ring |
| B040FRN26 | Annuloplasty Ring |
| B040FRN240 | Annuloplasty Ring |
| B040FRH40 | Annuloplasty Ring |
| B040FRH38 | Annuloplasty Ring |
| B040FRH36 | Annuloplasty Ring |
| B040FRH34 | Annuloplasty Ring |
| B040FRH32 | Annuloplasty Ring |
| B040FRH30 | Annuloplasty Ring |
| B040FRH28 | Annuloplasty Ring |
| B040FRH26 | Annuloplasty Ring |
| B040FRH24 | Annuloplasty Ring |