AccessGUDID - DEVICE: Durashield® (D687AD311021)

GUDID

Device Identifier (DI) Information

Brand Name: Durashield®
Version or Model: AD31102
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Sultan Healthcare Inc

Primary DI Number: D687AD311021
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2019
Device Count: 200
Labeler D-U-N-S® Number*: 056296981 *Terms of Use

Device Description: Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL

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 [?]
K982915	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: more than 30 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.4 Milliliter

Device Record Status

Public Device Record Key: 0401e008-e13a-4e44-8e3b-385d3cbbfd52
Public Version Date: October 31, 2019
Public Version Number: 5
DI Record Publish Date: September 23, 2016