Duns Number:187129135
Device Description: Indicated for surgical clamping during cardiovascular peripheral vascular, and general sur Indicated for surgical clamping during cardiovascular peripheral vascular, and general surgery.
Catalog Number
-
Brand Name
Soft/Fibra® Spring Clip
Version/Model Number
G-6050
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"
Yes
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
DSS
Product Code Name
Clip, Vascular
Public Device Record Key
30151068-6cdc-453a-b9e9-f10b69422c20
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 20, 2015
Package DI Number
10607915118010
Quantity per Package
15
Contains DI Package
00607915118013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |