Duns Number:068199363
Device Description: The Defendo Sigle Use Valve kit 4-piece kit includes Air Water, Suction and Biopsy Valves The Defendo Sigle Use Valve kit 4-piece kit includes Air Water, Suction and Biopsy Valves and a Cleaning Adapter.
Catalog Number
100323
Brand Name
DEFENDO SINGLE USE VALVE KIT
Version/Model Number
100323
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
de1ae15d-835f-48a2-af25-fb424ea11fa3
Public Version Date
July 19, 2022
Public Version Number
9
DI Record Publish Date
June 04, 2019
Package DI Number
40677964010604
Quantity per Package
50
Contains DI Package
00677964103926
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 |