| Primary Device ID | B356111MD27S1 |
| NIH Device Record Key | edb4e24f-03cd-4e5d-88ee-831a1d98dfd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | American Medicals |
| Version Model Number | 1 |
| Company DUNS | 109909627 |
| Company Name | American Medicals |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B356111MD27S0 [Primary] |
| HIBCC | B356111MD27S1 [Package] Contains: B356111MD27S0 Package: [40 Units] In Commercial Distribution |
| GFF | Bur, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-12 |
| Device Publish Date | 2022-09-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMERICAN MEDICALS 98716697 not registered Live/Pending |
Bihani Corporation 2024-08-26 |