Duns Number:023055619
Device Description: Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Maxi Straight Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Maxi Straight (orange), clamping pressure 165-175 g (1/sterile pkg)
Catalog Number
1001-544
Brand Name
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres
Version/Model Number
1001-544
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
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
c45898f5-c141-4e74-8fc8-1289d79bb275
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 14, 2017
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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |