Duns Number:068199363
Device Description: Endogator Kit includes Endogator Irrigation Tubing for Endogator EGP-100 Irrigation pump, Endogator Kit includes Endogator Irrigation Tubing for Endogator EGP-100 Irrigation pump, Olympus OFP Pump, gi4000 ESU or Torrent Irrigation Pump, and ENDO SMARTCAP Rinse and insufflation Tubing for PENTAX GI Endoscopes.
Catalog Number
4005472
Brand Name
Endogator Kit
Version/Model Number
4005472
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
-
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
K102855,K102855,K102855
Product Code
OCX
Product Code Name
endoscopic irrigation/suction system
Public Device Record Key
1cfa3d46-ba33-4a40-b3b9-869141462874
Public Version Date
July 22, 2022
Public Version Number
1
DI Record Publish Date
July 14, 2022
Package DI Number
40677964028142
Quantity per Package
10
Contains DI Package
40677964028135
Package Discontinue Date
-
Package Status
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 | 2999 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 362 |