AccessGUDID - DEVICE: Waterpik UltraClear Fluoride Varnish (Bubblegum) (D6862002125235)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik UltraClear Fluoride Varnish (Bubblegum)
Version or Model: 20021252
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20021252
Company Name: WATER PIK, INC.

Primary DI Number: D6862002125235
Issuing Agency: HIBCC
Commercial Distribution End Date: April 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Fluoride Varnish, Box of 30 single dose (0.40ml) (Bubblegum flavor)

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):	No
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?
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	Varnish, 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
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 393ec283-a945-426f-8aa1-c9a2b6c80e35
Public Version Date: April 27, 2023
Public Version Number: 4
DI Record Publish Date: August 12, 2016