Duns Number:068199363
Device Description: ENDOGATOR for Pentax Pump
Catalog Number
-
Brand Name
ENDOGATOR
Version/Model Number
200230P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2022
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
-
Product Code
FEQ
Product Code Name
Pump, Air, Non-Manual, For Endoscope
Public Device Record Key
0ef51eff-85e5-429d-be85-4fb4ce72b93c
Public Version Date
May 04, 2022
Public Version Number
6
DI Record Publish Date
August 16, 2018
Package DI Number
20677964060889
Quantity per Package
50
Contains DI Package
00677964060885
Package Discontinue Date
May 03, 2022
Package Status
Not 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 |