Duns Number:711789789
Device Description: DISPOSABLE CYTOLOGY BRUSH
Catalog Number
-
Brand Name
DISPOSABLE CYTOLOGY BRUSH
Version/Model Number
BC-23Q
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 23, 2022
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"
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
K902737,K902737
Product Code
FDX
Product Code Name
endoscopic cytology brush
Public Device Record Key
987e3520-975b-4e6b-8033-420b57b0e9c8
Public Version Date
June 24, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
14953170042819
Quantity per Package
3
Contains DI Package
04953170042812
Package Discontinue Date
June 23, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 117 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
| U | Unclassified | 52 |