AccessGUDID - DEVICE: Young (00302730901009)

GUDID

Device Identifier (DI) Information

Brand Name: Young
Version or Model: 090100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 090100
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302730901009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Young Standard Prophy Brush, Firm, Long Flat Black Brush, Screw Type, Bulk Buy

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

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: b53832bd-36c5-4e61-b76c-5b6d9f2332f2
Public Version Date: October 24, 2022
Public Version Number: 1
DI Record Publish Date: October 16, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10302730901006	1	00302730901009		In Commercial Distribution	Bag

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800) 325-1881
Email: customerservice@younginnovations.com

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