AccessGUDID - DEVICE: SKY CHOICE (00850023750426)

GUDID

Device Identifier (DI) Information

Brand Name: SKY CHOICE
Version or Model: KY1298
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KY1298
Company Name: Hexa Dental

Primary DI Number: 00850023750426
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 096955608 *Terms of Use

Device Description: Sky Choice Prophy Paste Splatter - Free Containing 1.23% Fluoride ( Medium) Assorted 200/Box

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?
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: 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: 2cfc4569-2b95-4eb7-a342-a93f9a65b622
Public Version Date: August 06, 2021
Public Version Number: 1
DI Record Publish Date: July 29, 2021