AccessGUDID - DEVICE: Medicon (04046826129521)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 69.01.09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 69.01.09
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826129521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: twist drill Ø 1.2x14mm 30mm dental

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?
10520	Cranial bur, reusable	A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEY	PLATE, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 77eb587e-0b89-4b62-a5a3-751f5424f89b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 10, 2016