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
000522
Brand Name
CONMED CLEARGUARD
Version/Model Number
000522
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
bb474cf9-1a3f-4465-a407-30f8b7ac577b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2017
Package DI Number
20653405063237
Quantity per Package
100
Contains DI Package
10653405063230
Package Discontinue Date
-
Package Status
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 |