AccessGUDID - DEVICE: Hermann Medizintechnik GmbH (04059453017819)

GUDID

Device Identifier (DI) Information

Brand Name: Hermann Medizintechnik GmbH
Version or Model: H118-27003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hermann Medizintechnik GmbH

Primary DI Number: 04059453017819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324868165 *Terms of Use

Device Description: VOLKMANN retractor, sharp,3 prongs, 4 1/2" 11,5 cm

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?
35110	Skin/tissue hook	A hand-held manual surgical instrument designed to hook skin or tissue in order to grasp, apply traction, and lift the skin/tissue during a surgical intervention. It is typically a shaft-like instrument with small double hooks at the distal end and a handle at the proximal end. The hooks are curved in opposite directions and when the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. Also known as a tissue pick, it is not unlike a hooked wound retractor. It is made of high-grade stainless steel and may be supplied with a cylindrical steel protecting sheath for storage and sterilization. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EIG	RETRACTOR, ALL TYPES

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: 23688302-8d14-4fc8-a5bc-a1fad0fac208
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 04, 2017