Duns Number:068199363
Device Description: ENDOGATOR Auxiliary Water Jet Connector for PENTAX GI Endoscopes
Catalog Number
100242
Brand Name
ENDOGATOR
Version/Model Number
100242
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
-
Product Code
FEQ
Product Code Name
Pump, Air, Non-Manual, For Endoscope
Public Device Record Key
8d04e45c-a5d5-40d4-97ff-5cc5c618f544
Public Version Date
May 03, 2022
Public Version Number
8
DI Record Publish Date
September 22, 2016
Package DI Number
20677964058497
Quantity per Package
50
Contains DI Package
00677964058493
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 | 2999 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 362 |