Duns Number:068199363
Device Description: ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, Olympus OFP and ENDO STRATUS Irrigation Pumps and the ENDO SMARTCAP Rinse and Insufflation Tubing for certain Olympus GI Endoscopes
Catalog Number
100602
Brand Name
ENDOGATOR Kit
Version/Model Number
100602
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,K102855
Product Code
OCX
Product Code Name
endoscopic irrigation/suction system
Public Device Record Key
acd6eb3b-b3e3-43d7-ad81-b9139d92de32
Public Version Date
July 13, 2022
Public Version Number
1
DI Record Publish Date
July 05, 2022
Package DI Number
20677964067284
Quantity per Package
2
Contains DI Package
10677964059633
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 |