AccessGUDID - DEVICE: Medicon (04046826151737)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 76.50.17
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76.50.17
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826151737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: burr fig 7 Ø 8mm

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?
46392	General/plastic surgery bur	A small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes of various shapes on one end, designed to excavate soft tissue or cartilage during general and/or plastic surgery. It is usually power-driven by a rotary handpiece or other powered device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXY	BRACE, DRILL

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: e4f3d102-aa0b-446c-95a7-9816c2fdad33
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020