AccessGUDID - DEVICE: Hermann Medizintechnik GmbH (04059453046703)

GUDID

Device Identifier (DI) Information

Brand Name: Hermann Medizintechnik GmbH
Version or Model: H120-16212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hermann Medizintechnik GmbH

Primary DI Number: 04059453046703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324868165 *Terms of Use

Device Description: Handle for vein-stripper, 4 3/4", 12cm

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):	No
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
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: 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: 87a94274-8240-47ac-8636-6e050ad51e5a
Public Version Date: December 23, 2021
Public Version Number: 1
DI Record Publish Date: December 15, 2021