FDA.report

Crosstex International

Primary DI
50732224000331
Brand
Crosstex International
Company
CROSSTEX INTERNATIONAL, INC.
Model
UFVM
Catalog number
UFVM
Device description
Sparkle V Sodium Fluoride Varnish Mint
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LBHVARNISH, CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50732224000331PackageGS15In Commercial Distribution
10732224000333PrimaryGS10
00732224000336Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400033150732224000331
1073222400033310732224000333
00732224000336007322240003367322240003360732224000336

GMDN Terms

TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com
1-585-359-0130regulatoryaffairs@hu-friedy.com

Regulatory Flags

DUNS number
057728685
Device count
120
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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