AccessGUDID - DEVICE: Mirror Magic® Clarity Collection (00840161308146)

GUDID

Device Identifier (DI) Information

Brand Name: Mirror Magic® Clarity Collection
Version or Model: 50R220
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161308146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use

Device Description: "Clarity Collection 10 x Anti-fog Solution 96 x Swipe Pads 1 x Crystal HD Mouth Mirror 1 x Mirror Magic Organizer"

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?
38788	Dental antifog solution	A liquid substance used to prevent the occurrence of condensed vapour (fog) on the mirrored surface of a dental instrument during treatment. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAX	Mirror, Mouth

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: 356 Millimeter
Width: 159 Millimeter
Height: 64 Millimeter

Device Record Status

Public Device Record Key: 71ff83de-c2c6-412b-b53d-552f86cdc910
Public Version Date: November 04, 2022
Public Version Number: 1
DI Record Publish Date: October 27, 2022