Duns Number:938289980
Device Description: A hand-held surgical instrument designed to compress the severed end of a small vessel (e. A hand-held surgical instrument designed to compress the severed end of a small vessel (e.g., blood vessel, vas deferens) to occlude the vessel, typically prior to anastomosis formation. Often referred to as an Acland clamp, it has an A-/V-shaped design whereby the vessel is slid into the mouth of the clamp up to the apex where it is compressed; it does not have a hinge/jaws (i.e., it is not forceps or a bulldog clamp). This is a reusable device intended to be sterilized prior to use.
Catalog Number
201003NS
Brand Name
Blue Vessel Clamp
Version/Model Number
201003NS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
985715eb-dbf3-4e8a-8cca-e671fc7e1070
Public Version Date
September 23, 2022
Public Version Number
3
DI Record Publish Date
October 06, 2015
Package DI Number
B066201003NS3
Quantity per Package
1000
Contains DI Package
B066201003NS1
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 |