AccessGUDID - DEVICE: 3M™ (J001702011055360)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™
Version or Model: 77121
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 77121
Company Name: 3M Deutschland GmbH

Primary DI Number: J001702011055360
Issuing Agency: HIBCC
Commercial Distribution End Date: April 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 77121 VISIO ALFA LIGHT UNIT 110V NA

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?
35761	Dental laboratory curing unit	A mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 2d8b6be4-c103-4663-bfeb-a97078a0356f
Public Version Date: December 10, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016