AccessGUDID - DEVICE: Ena Shiny (EMICESDF1)

GUDID

Device Identifier (DI) Information

Brand Name: Ena Shiny
Version or Model: ESDF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ESDF
Company Name: MICERIUM SPA

Primary DI Number: EMICESDF1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Ena Shiny Composite Finishing Discs 100 pcs Superfine grain mini discs Max speed 10.000 rpm

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:	Yes
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?
64617	Dental abrasive disk, single-use	A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHJ	Disk, Abrasive

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: 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: 8fd2c415-0dff-448b-8fcd-a79c55cf625f
Public Version Date: December 13, 2021
Public Version Number: 1
DI Record Publish Date: December 03, 2021