FDA.reportPublic FDA data

McKesson

Primary DI
20612479229314
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
184-FV35
Device description
5% Sodium Fluoride Varnish BUBBLEGUM WITH XYLITOL 0.4 mL
Published
2018-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479229314PrimaryGS10
10612479230924Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247922931420612479229314
1061247923092410612479230924

GMDN Terms#

Term, Definition table
TermDefinition
Fluoride gelA preparation in the form of a gel, containing fluorine, in a chemical form and sufficient concentration to permit the treatment of tooth tissues by topical application. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
35
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006606740Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606757Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbHLBH2026-07-26
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10