Duns Number:202659140
Device Description: The Pentax Leak Test Adapter is used with the Acu-sinQ Complete Endoscope Cleaning Aid Sy The Pentax Leak Test Adapter is used with the Acu-sinQ Complete Endoscope Cleaning Aid System.
Catalog Number
7117185PKN
Brand Name
NA
Version/Model Number
7117161PKN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181865
Product Code
FEB
Product Code Name
Accessories, cleaning, for endoscope
Public Device Record Key
15600899-75ae-44ed-a3ab-5351f0a5af03
Public Version Date
August 09, 2021
Public Version Number
6
DI Record Publish Date
February 28, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |