AccessGUDID - DEVICE: Hermann Medizintechnik GmbH (04059453018175)

GUDID

Device Identifier (DI) Information

Brand Name: Hermann Medizintechnik GmbH
Version or Model: H168-20023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hermann Medizintechnik GmbH

Primary DI Number: 04059453018175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324868165 *Terms of Use

Device Description: VERNON-DAVID anoscope, 17X23mmlength: 75mm, with plasitc obturator

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?
10156	Optical anoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. 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: 1929bb8e-b2bc-4178-837b-5144e41d0854
Public Version Date: November 17, 2023
Public Version Number: 3
DI Record Publish Date: July 04, 2017