Primary Device ID | M722C20167V201320 |
NIH Device Record Key | 42108618-0a62-48a9-9f94-dc34742c3d8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ClearRead CT |
Version Model Number | 3.6.0 |
Company DUNS | 172223922 |
Company Name | Riverain Technologies, LLC |
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 | false |
Lot Batch | false |
Serial Number | true |
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 | M722C20167V201320 [Primary] |
OEB | Lung Computed Tomography System, Computer-Aided Detection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-14 |
Device Publish Date | 2020-08-06 |
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