| Primary Device ID | B356AM913501 | 
| NIH Device Record Key | 3367e78b-30e9-438a-a8aa-2df3c655651c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | American Medicals | 
| Version Model Number | 1 | 
| Company DUNS | 109909627 | 
| Company Name | American Medicals | 
| Device Count | 10 | 
| 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 | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B356AM913500 [Primary] | 
| HIBCC | B356AM913501 [Package] Contains: B356AM913500 Package: [50 Units] In Commercial Distribution | 
| HIBCC | B356AM913505 [Unit of Use] | 
| FQM | Bandage, Elastic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-09-12 | 
| Device Publish Date | 2022-09-02 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AMERICAN MEDICALS  98716697  not registered Live/Pending | Bihani Corporation 2024-08-26 |