Duns Number:103318015
Catalog Number
490520
Brand Name
PrepStain® Settling Chambers
Version/Model Number
490520
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2015
Issuing Agency
In GS1
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P970018,P970018
Product Code
MKQ
Product Code Name
Processor, Cervical Cytology Slide, Automated
Public Device Record Key
2a08c648-172b-4b5c-8d86-8ba074fca20e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 05, 2015
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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 17 |