Duns Number:402155084
Device Description: EndoCervical cell sampler
Catalog Number
-
Brand Name
Rovers® EndoCervex-Brush®
Version/Model Number
380100703
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
K001119,K001119,K001119
Product Code
HHT
Product Code Name
Spatula, Cervical, Cytological
Public Device Record Key
4bbbdafb-f2bb-47da-9ea5-0f56ca88a7c8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 20, 2017
Package DI Number
08719189246117
Quantity per Package
20
Contains DI Package
08719189246100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box