AccessGUDID - DEVICE: Young (00302732950661)

GUDID

Device Identifier (DI) Information

Brand Name: Young
Version or Model: 295066
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13226938
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302732950661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Young Centwins, Anatomically Contoured Fluoride Trays - Hinged, Large, 50ct - 13226938

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?
35701	Fluoride gel tray	A device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMT	TRAY, FLUORIDE, DISPOSABLE

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: dddda384-adb2-44f9-8a1f-c73a16dbaee4
Public Version Date: November 10, 2022
Public Version Number: 2
DI Record Publish Date: October 16, 2022