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 |