AccessGUDID - DEVICE: Zooby (00302736001109)

GUDID

Device Identifier (DI) Information

Brand Name: Zooby
Version or Model: 600110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 600110
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302736001109
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: Zooby Prophy Paste, Assorted, Medium Grit

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?
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY

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: e71733c1-9715-496c-bf9d-d43451b1b2f2
Public Version Date: April 15, 2024
Public Version Number: 3
DI Record Publish Date: October 16, 2022