Duns Number:938289980
Device Description: A sterile, hand-held manual surgical instrument designed to directly compress a blood vess A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.
Catalog Number
201003-000
Brand Name
VESSEL CLAMP, BLUE
Version/Model Number
201003-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K801395,K801395,K801395,K801395,K801395
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
0f541c45-77ee-47cd-9aef-51e2369ee462
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 26, 2016
Package DI Number
B0662010030006
Quantity per Package
100
Contains DI Package
B0662010030000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |