AccessGUDID - DEVICE: Denticator (00302735028503)

GUDID

Device Identifier (DI) Information

Brand Name: Denticator
Version or Model: 502850
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 502850
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302735028503
Issuing Agency: GS1
Commercial Distribution End Date: April 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Denticator Denticolors DPA, Assorted Colors, Latex Free, Soft, Short, Web Cup, Snap On Type

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):	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
EGS	Handpiece, contra- and right-angle attachment, dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 2 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 271c81e7-d392-4093-a94c-9b95123a9df1
Public Version Date: April 15, 2024
Public Version Number: 3
DI Record Publish Date: October 16, 2022