Duns Number:544434963
Device Description: ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes
Catalog Number
000522
Brand Name
Disposable Biopsy Valve
Version/Model Number
MDBV1A0000A
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
K173758,K173758,K173758
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
da470c43-649c-47d4-b57d-dbe27c46f080
Public Version Date
July 18, 2022
Public Version Number
3
DI Record Publish Date
June 18, 2019
Package DI Number
26970401814057
Quantity per Package
500
Contains DI Package
16970401814043
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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 147 |