Duns Number:001101419
Device Description: Non-sterile Histobrush Cytology Brush. 7" length, plastic handle, soft nylon bristle head Non-sterile Histobrush Cytology Brush. 7" length, plastic handle, soft nylon bristle head.
Catalog Number
2199
Brand Name
Puritan Histobrush Cytology Brush
Version/Model Number
Histobrush
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
K111681,K111681,K111681
Product Code
HHT
Product Code Name
Spatula, Cervical, Cytological
Public Device Record Key
69fa1248-d4e9-4b65-b40a-50285ee1ffce
Public Version Date
August 26, 2020
Public Version Number
4
DI Record Publish Date
May 31, 2016
Package DI Number
50609576250076
Quantity per Package
1000
Contains DI Package
30609576250072
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |