AccessGUDID - DEVICE: VESSEL CLAMP, BLUE (B066201003NS1)

GUDID

Device Identifier (DI) Information

Brand Name: VESSEL CLAMP, BLUE
Version or Model: 201003NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201003NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066201003NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63552	Surgical A/V-shaped microvessel clamp	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801395	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 985715eb-dbf3-4e8a-8cca-e671fc7e1070
Public Version Date: July 13, 2023
Public Version Number: 4
DI Record Publish Date: October 06, 2015