Duns Number:121464288
Device Description: Reusable Appliers for implantable clips PVC320-1B (Medium Large C Applier)
Catalog Number
-
Brand Name
Vitalitec Clip Appliers
Version/Model Number
PVC320-1B
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
-
Product Code
HBT
Product Code Name
Applier, Hemostatic Clip
Public Device Record Key
62ee6b0b-1a30-4f79-9205-b94c54814b9a
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
June 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 163 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |