AccessGUDID - DEVICE: MEDICOM DURAFLOR ULTRA (20686864055901)

GUDID

Device Identifier (DI) Information

Brand Name: MEDICOM DURAFLOR ULTRA
Version or Model: 1016-A400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1016-A400
Company Name: AMD Medicom Inc

Primary DI Number: 20686864055901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: DURAFLOR ULTRA VARNISH 5% FLUORIDE ASSORTED FLAVORS - 400 units (MINT - 00686864040996 - 200 unities) (CARAMEL - 00686864041009 - 50 unities) (STRAWBERRY- 00686864041016 - 150 unities)

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?
64794	Dental coating, tooth-desensitizing, professional	A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. 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
Handling Environment Temperature: between 59 and 82 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.4 Milliliter

Device Record Status

Public Device Record Key: df0ed6d7-1826-4c28-a89f-1f51447cea13
Public Version Date: July 23, 2020
Public Version Number: 1
DI Record Publish Date: July 15, 2020