AccessGUDID - DEVICE: Classic Disposable Mouth Mirrors (00723896019733)

GUDID

Device Identifier (DI) Information

Brand Name: Classic Disposable Mouth Mirrors
Version or Model: 7158215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7158215
Company Name: PRACTICON, INC.

Primary DI Number: 00723896019733
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: PRE-STERILIZED, SINGLE USE DENTAL MOUTH 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":	Yes
For Single-Use:	Yes
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?
64029	Dental mirror, single-use	A sterile, 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 single-use 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: Yes
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: fbb4e666-612c-4d4b-819a-b8066e9d4dc5
Public Version Date: August 02, 2021
Public Version Number: 1
DI Record Publish Date: July 23, 2021