AccessGUDID - DEVICE: Crystal HD® Mouth Mirrors (00840161305756)

GUDID

Device Identifier (DI) Information

Brand Name: Crystal HD® Mouth Mirrors
Version or Model: 50Z353-JWL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161305756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use

Device Description: "Crystal HD Assorted Thin Grip 12pk-Jewel #4 2 x Plum 2 x Midnight Blue 2 x Gray 2 x Teal 2 x Red 2 x Copper"

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?
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	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
Outer Diameter: 22 Millimeter

Device Record Status

Public Device Record Key: b10943c4-5c8c-44f4-9f91-f9eedd22f5b3
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022