Duns Number:071595540
Device Description: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSC CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES
Catalog Number
00522B
Brand Name
CONMED CLEARGUARD
Version/Model Number
00522B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 30, 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
K090851,K090851,K090851
Product Code
ODC
Product Code Name
Endoscope channel accessory
Public Device Record Key
b1c2b075-5aae-4317-8b7e-eaa7fbe8ba98
Public Version Date
June 01, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2017
Package DI Number
10653405063247
Quantity per Package
400
Contains DI Package
20653405063244
Package Discontinue Date
October 21, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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 |