Duns Number:402155084
Device Description: Cervical cell sampler
Catalog Number
-
Brand Name
Rovers® Cervex-Brush® RT
Version/Model Number
380300324
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K930955,K930955
Product Code
HHT
Product Code Name
Spatula, Cervical, Cytological
Public Device Record Key
67aea279-ed1c-4336-bf89-f116a9587643
Public Version Date
August 16, 2018
Public Version Number
1
DI Record Publish Date
July 16, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-