AccessGUDID - DEVICE: Temp Silicon Brush (EMICSS30)

GUDID

Device Identifier (DI) Information

Brand Name: Temp Silicon Brush
Version or Model: SS3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS3
Company Name: MICERIUM SPA

Primary DI Number: EMICSS30
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Temp Silicon Brush Silicon Brushes for composite application S3 silicon tip round-flat shape for modelling cervical areas.

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?
63953	Dental material application tool, reusable	A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJB	Handle, Instrument, 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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 14.7 Centimeter

Device Record Status

Public Device Record Key: bb320e12-6a21-44d8-9e98-f293811b90e7
Public Version Date: December 03, 2019
Public Version Number: 1
DI Record Publish Date: November 25, 2019