AccessGUDID - DEVICE: Mirror Magic® (00840161308092)

GUDID

Device Identifier (DI) Information

Brand Name: Mirror Magic®
Version or Model: 50R200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161308092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use

Device Description: "Mirror Magic Trial Kit 2 x 6mL Anti-Fog Solution 24 x Swipe Pads"

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):	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: 95 Millimeter
Width: 92 Millimeter
Height: 48 Millimeter

Device Record Status

Public Device Record Key: 9fd47ce4-7c41-4d4c-85b6-5e37f3705afc
Public Version Date: November 04, 2022
Public Version Number: 1
DI Record Publish Date: October 27, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES