Duns Number:202659140
Device Description: The Quick Connects for Pentax X/00/01/P Series Gastroscopes without Water Jets are and VSB The Quick Connects for Pentax X/00/01/P Series Gastroscopes without Water Jets are and VSB-2900 used with C1160E Universal Flexible Processing Trays in the System 1E Liquid Chemical Processing System.
Catalog Number
QPC1673E
Brand Name
NA
Version/Model Number
Quick Connect
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 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
-
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
-
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
c22a01c5-a0cf-464f-8a10-b6d522387bc5
Public Version Date
June 22, 2021
Public Version Number
11
DI Record Publish Date
September 13, 2016
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 |