| Primary Device ID | B356KE346120 |
| NIH Device Record Key | b61bd103-184d-4e2b-a25e-3e775924ea0a |
| 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 | B356KE346120 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
[B356KE346120]
Microwave Radiation
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-04-28 |
| Device Publish Date | 2023-01-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMERICAN MEDICALS 98716697 not registered Live/Pending |
Bihani Corporation 2024-08-26 |