Duns Number:076769355
Device Description: The Nasal Cytology Brush consists of bristles at the distal end which is then set into a h The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.
Catalog Number
4291
Brand Name
Hobbs Nasal Cytology Brush
Version/Model Number
4291
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
K834402,K834402
Product Code
FDX
Product Code Name
Endoscopic Cytology Brush
Public Device Record Key
f5927aaa-3db5-4ca7-95ab-128376b143a5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
M84942912
Quantity per Package
10
Contains DI Package
M84942910
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |