| Primary Device ID | B040420032 |
| NIH Device Record Key | 696d7435-6872-46c2-ae7d-1a461bfb046d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoForm |
| Version Model Number | 4200-32 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040420032 [Package] Contains: B0404200320 Package: [1 Units] In Commercial Distribution |
| HIBCC | B0404200320 [Primary] |
| KRH | Ring, Annuloplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-30 |
| Device Publish Date | 2019-05-22 |
| B040420032 | Annuloplasty Ring |
| B040420030 | Annuloplasty Ring |
| B040420028 | Annuloplasty Ring |
| B0404200260 | Annuloplasty Ring |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEOFORM 87720950 5814328 Live/Registered |
Genesee BioMedical, Inc. 2017-12-14 |
![]() NEOFORM 78974713 3413537 Dead/Cancelled |
MENTOR WORLDWIDE LLC 2006-09-14 |
![]() NEOFORM 78848110 3272091 Dead/Cancelled |
DENTSPLY INTERNATIONAL INC. 2006-03-28 |
![]() NEOFORM 77010092 3294538 Live/Registered |
Trico Products Corporation 2006-09-28 |
![]() NEOFORM 75476258 2517787 Live/Registered |
DEXTER MAGNETIC TECHNOLOGIES, INC. 1998-04-29 |
![]() NEOFORM 75112781 not registered Dead/Abandoned |
Flexor, Inc. 1996-06-03 |
![]() NEOFORM 74336871 1870451 Dead/Cancelled |
ROYCE MEDICAL COMPANY 1992-12-04 |