AccessGUDID - DEVICE: Medicon (04046826184292)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 378.12.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 378.12.01
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826184292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: cement spatula d/e

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?
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL

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: c2b7f988-96c3-4dd8-9341-01f9f5c6d544
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020