AccessGUDID - DEVICE: Mirro-Vac Saliva Ejector Mirrors (00723896010006)

GUDID

Device Identifier (DI) Information

Brand Name: Mirro-Vac Saliva Ejector Mirrors
Version or Model: 70-42615
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-42615
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Reduce number of hands needed, instruments used and procedure time! The Mirro-Vac Saliva Ejector Mirror combines evacuator and mirror functions into one efficient instrument. Ideal for sealants, air abrasion, bonding and other dry field procedures. Upper suction inlet relieves tissue grab and ensures anti-fog acrylic mirror stays clear-even under direct exhalation. Size 4 lens with 35 degree inclination delivers standard mouth mirror feel and function without compromise. Easy-lift film protects mirror surface until use.Soft blue color eases patient anxiety.Round, knurled handle improves grip.Fully disposable, one-piece construction eliminates need for sterilization. 6" long. 50 mirrors per bag.

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):	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
EHZ	Evacuator, Oral Cavity

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: 4119a83a-8d47-4d58-8545-f1bb0c764bab
Public Version Date: December 21, 2018
Public Version Number: 2
DI Record Publish Date: July 18, 2018