AccessGUDID - DEVICE: Fog-Free Photo Mirror Kit (00723896023747)

GUDID

Device Identifier (DI) Information

Brand Name: Fog-Free Photo Mirror Kit
Version or Model: 7160914
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7160914
Company Name: PRACTICON, INC.

Primary DI Number: 00723896023747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: The Practicon® Fog-Free Photo Mirror features interchangeable polished stainless mirrors that slide securely into a lightweight plastic handle. Inside the handle, a battery-powered fan directs a gentle stream of air across the mirror surface to eliminate fogging. Five built-in LEDs help illuminate mouth for brighter photos and better focusing. Rechargeable, cordless operation with low battery indicator. Auto shut-off. Handle may be surface disinfected. Mirrors are fully autoclavable. One year warranty. Kit includes handle, USB charging cable, and one each L occlusal, M occlusal, buccal, and lingual mirrors.

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?
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
No Device Sizes

Device Record Status

Public Device Record Key: 523e485e-46a0-4665-8bbb-fd66a1cb1f3f
Public Version Date: September 01, 2023
Public Version Number: 1
DI Record Publish Date: August 24, 2023