AccessGUDID - DEVICE: Waterpik Ultra Thin & Clear Varnish (D686200306763)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik Ultra Thin & Clear Varnish
Version or Model: 20030676
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20030676
Company Name: WATER PIK, INC.

Primary DI Number: D686200306763
Issuing Agency: HIBCC
Commercial Distribution End Date: February 20, 2024
Device Count: 30
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: 5% Sodium Fluoride, Strawberry 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):	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?
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 [?]
K040098	000

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 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.40 Milliliter

Device Record Status

Public Device Record Key: 82d7aab4-9248-4125-ba25-6ee0c453c6c8
Public Version Date: March 20, 2024
Public Version Number: 3
DI Record Publish Date: October 22, 2021