| Primary Device ID | B356KD577020 |
| NIH Device Record Key | d83961e1-2a9c-4971-a70a-ddc5cf788383 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B356KD577020 [Primary] |
| EMJ | Elevator, Surgical, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
[B356KD577020]
Microwave Radiation
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-24 |
| Device Publish Date | 2025-07-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMERICAN MEDICALS 98716697 not registered Live/Pending |
Bihani Corporation 2024-08-26 |