Primary Device ID | B634SW0121930202000 |
NIH Device Record Key | 7bd2d543-50ef-49b8-9c62-6573dd6f0de3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Monarch Software Cart v2.2.1 |
Version Model Number | Version 2.2.1 |
Company DUNS | 015823456 |
Company Name | AURIS HEALTH, INC. |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B634SW0121930202000 [Primary] |
JAK | System, X-Ray, Tomography, Computed |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-13 |
Device Publish Date | 2020-03-05 |
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