MEDICOM DURAFLOR ULTRA

Basic Information

• Brand Name: MEDICOM DURAFLOR ULTRA
• Primary DI: 20686864041010
• Version / Model: 1016-ST200
• Catalog Number: 1016-ST200
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 6
• Public Version Date: 2022-04-19
• Public Version Status: Update
• Public Device Record Key: 3aec0ef6-83fe-4bd8-bb87-fb45b85a5293

Device Description

DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	VARNISH, CAVITY	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20686864041010	GS1
Unit of Use	00686864041016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone] ext. 2309
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	0.4	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 28 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 82 Degrees Fahrenheit