Duns Number:071595540
Device Description: CONMED DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH
Catalog Number
158R
Brand Name
NA
Version/Model Number
158R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 04, 2021
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
-
Product Code
FDX
Product Code Name
endoscopic cytology brush
Public Device Record Key
3b96b86a-9814-4573-aebf-e66420910211
Public Version Date
September 06, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653404042316
Quantity per Package
20
Contains DI Package
10653404042319
Package Discontinue Date
September 04, 2021
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |