Duns Number:825239189
Device Description: Flexible endoscopic cytology brush
Catalog Number
CB-1315
Brand Name
Cytology Brush
Version/Model Number
CB-1315
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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
-
Product Code
FDX
Product Code Name
Endoscopic Cytology Brush
Public Device Record Key
bf49c17a-8f8b-40cc-9719-adb9b963e01e
Public Version Date
November 05, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10816207020522
Quantity per Package
10
Contains DI Package
00816207020525
Package Discontinue Date
November 04, 2019
Package Status
Not 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |