Duns Number:068199363
Device Description: Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, and Defendo Air, Water, Suct Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, and Defendo Air, Water, Suction and Biopsy Valves.
Catalog Number
4006151
Brand Name
Endo-Carry-on Procedure Kit
Version/Model Number
4006151
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
NWU
Product Code Name
Endoscope introducer kit
Public Device Record Key
e9a55bb3-0c00-4b8e-9786-6ec2e3555ff2
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
Package DI Number
40677964032934
Quantity per Package
14
Contains DI Package
40677964032927
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 |