AccessGUDID - DEVICE: Mirror Cotton Holders (00723896010068)

GUDID

Device Identifier (DI) Information

Brand Name: Mirror Cotton Holders
Version or Model: 1604-P01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-42625
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and buccal cotton rolls in place during lower posterior procedures. Easily reversible for left or right quadrants. 100 single-use, disposable holders per bag. Not for use with Zirc 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":	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?
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. 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: 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: 1fb1bd09-f843-4d59-8164-506dd0fa0cbd
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 18, 2018