AccessGUDID - DEVICE: NUPRO® (D0031303271)

GUDID

Device Identifier (DI) Information

Brand Name: NUPRO®
Version or Model: 130327
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dentsply Professional

Primary DI Number: D0031303271
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 144140845 *Terms of Use

Device Description: NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Raspberry. Contents: Integrated Brush, 100 Patient Doses of 0.4g.

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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep out of direct sunlight. Keep dry.
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.4 Gram

Device Record Status

Public Device Record Key: 51c12466-d878-4582-8a82-65d6a130a970
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016