Duns Number:604056226
Device Description: Disposable Endoscope Valve Kit, Air Water Suction Biospy Valves, Pentax
Catalog Number
-
Brand Name
Key Surgical Endoscope Valves
Version/Model Number
EN10229PB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 14, 2022
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
K191231,K191231,K191231
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
a2044544-5dbc-44bb-a851-97f3d84d37c6
Public Version Date
June 14, 2022
Public Version Number
5
DI Record Publish Date
April 05, 2021
Package DI Number
00849771041313
Quantity per Package
50
Contains DI Package
00849771041306
Package Discontinue Date
June 08, 2022
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |