AccessGUDID - DEVICE: Prophy Rubber Cup (08806383525862)

GUDID

Device Identifier (DI) Information

Brand Name: Prophy Rubber Cup
Version or Model: Umbrella Shape, Screw Type
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 950-232
Company Name: DiaDent Group International

Primary DI Number: 08806383525862
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

Device Description: A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning).

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):	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?
64015	Dental-professional prophylaxis brush, single-use	A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.	Active	false
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHK	Cup, Prophylaxis

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
Special Storage Condition, Specify: Keep Dry and Keep away from Sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aff5f381-ac6a-4f0a-9b22-c04e0412862c
Public Version Date: August 21, 2020
Public Version Number: 1
DI Record Publish Date: August 13, 2020