Duns Number:265741780
Device Description: Titanium Hemostatic Clip - Large Size
Catalog Number
O4120-1
Brand Name
SLS-CLIP VITALITEC
Version/Model Number
O4120-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
40e86bff-316b-4423-b77f-f880af408298
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
13661522039523
Quantity per Package
20
Contains DI Package
03661522039526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 839 |