Primary Device ID | 05713315008856 |
NIH Device Record Key | 3dc4aad6-c85a-418c-a6c0-1e16974008c5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 1077 AccuScreen |
Version Model Number | 8-04-13904 |
Company DUNS | 306633756 |
Company Name | Gn Otometrics A/S |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05713315008856 [Primary] |
GWJ | Stimulator, Auditory, Evoked Response |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-04 |
Device Publish Date | 2021-04-26 |
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