AccessGUDID - DEVICE: n/a (E0HM3600GDH0100231)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: GDH 023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GDH 023
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: E0HM3600GDH0100231
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 318034329 *Terms of Use

Device Description: Manual instrument for dental/surgical application

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?
35289	Skin-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

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: df025212-9e94-41bc-afc3-9d6e024bde83
Public Version Date: September 23, 2021
Public Version Number: 1
DI Record Publish Date: September 15, 2021