AccessGUDID - DEVICE: V. Mueller (10885403160288)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: SU11710
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SU11710
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403160288
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller MYERS INTERCHANGABLE VEIN STRIPPER COMPLETE SET STAFF LENGTH 39-3/8" (100CM)

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:	No
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?
35377	Vein stripper, reusable	A 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAI	STRIPPER, VEIN, REUSABLE

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: fb137493-043b-435a-8ffb-8ad4ef3de8f4
Public Version Date: March 09, 2022
Public Version Number: 3
DI Record Publish Date: September 17, 2018