AccessGUDID - DEVICE: Contours Disposable Prophy Angles Soft Cup (00723896010020)

GUDID

Device Identifier (DI) Information

Brand Name: Contours Disposable Prophy Angles Soft Cup
Version or Model: 70-42616
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-42616
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: a smooth, sculpted, low-profile design to maximize patient comfort and posterior access. The thin-walled, webbed cups flare consistently with moderate pressure to polish all “contours” and reach deep into interproximal spaces. Permanently sealed construction eliminates drive shaft separation. Unique lubricated gearing provides high torque and quiet dependability. Soft gray cups. Made without using natural rubber latex.

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad87bcc2-b4bd-47be-a877-8875b1dc233d
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 18, 2018