AccessGUDID - DEVICE: n/a (E0HM33000921)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: 3300092
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3300092
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: E0HM33000921
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
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?
45320	Dental drill bit extension	A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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: 77f7545e-61cb-4e43-bb29-83247ee0d3b7
Public Version Date: September 23, 2021
Public Version Number: 1
DI Record Publish Date: September 15, 2021