Primary Device ID | EDET038921 |
NIH Device Record Key | a4d0625a-600d-42ef-83a3-9846ed077785 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | earflex black 25 shore 8x50ml |
Version Model Number | 03892 |
Company DUNS | 343947949 |
Company Name | DETAX GmbH |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |