Duns Number:172223922
Device Description: ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-enter ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-entered 12/30/2020.
Catalog Number
-
Brand Name
ClearRead Detect Docker
Version/Model Number
5.3.1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2020
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MYN
Product Code Name
Analyzer,Medical Image
Public Device Record Key
fd78095d-d71b-4e26-802a-cde50e713756
Public Version Date
May 11, 2022
Public Version Number
3
DI Record Publish Date
May 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 221 |