AccessGUDID - DEVICE: Disposable Vein Hook (M20678000)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Vein Hook
Version or Model: 7800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20678000
Issuing Agency: HIBCC
Commercial Distribution End Date: April 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The Disposable Vein Hook is intended for single patient use for the treatment of superficial varicose veins and varicosities associated with superficial reflux and incompetence of the Great Saphenous Vein in the lower extremities.

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?
32321	Vein stripper, single-use	A sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAJ	Stripper, Vein, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: c7e34410-3f3b-4ee0-8b93-5855cdacf370
Public Version Date: February 22, 2022
Public Version Number: 3
DI Record Publish Date: September 05, 2016