| Primary Device ID | B356ED107160 |
| NIH Device Record Key | 6f7dd1b5-a134-43f8-bb4e-8086118ecf6f |
| 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 | 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 | 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 | B356ED107160 [Primary] |
| EMH | Forceps, Rongeur, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
[B356ED107160]
Microwave Radiation
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMERICAN MEDICALS 98716697 not registered Live/Pending |
Bihani Corporation 2024-08-26 |