FDA.reportPublic FDA data

VK Couture

Primary DI
00037741702184
Brand
VK Couture
Company
Diversified Products, Inc.
Model
7021-300
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HOISpectacle, Magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00037741702184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00037741702184000377417021840377417021840037741702184

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
604170506
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842894147702Trifocus BlueBX2201-1252022-12-05
00842894147719Trifocus BlueBX2201-1502022-12-05
00842894147726Trifocus BlueBX2201-1752022-12-05
00037741290032Clear Readers2900-1752022-11-30
00037741290049Clear Readers2900-2002022-11-30
00037741290056Clear Readers2900-2252022-11-30
00037741290063Clear Readers2900-2502022-11-30
00037741290070Clear Readers2900-2752022-11-30
00037741290087Clear Readers2900-3002022-11-30
00037741290094Clear Readers2900-3502022-11-30
00037741405009Sportex4050-1002022-11-30
00037741405016Sportex4050-1252022-11-30
00037741405023Sportex4050-1502022-11-30
00037741405030Sportex4050-1752022-11-30
00037741405047Sportex4050-2002022-11-30
00037741405054Sportex4050-2252022-11-30
00037741405061Sportex4050-2502022-11-30
00037741405078Sportex4050-2752022-11-30
00037741405085Sportex4050-3002022-11-30
00037741406006Sportex4060-1002022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770433667Bausch + LombBausch & Lomb IncorporatedHOI2025-10-13
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00628120772753AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772791AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772814AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772821AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772838AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772852AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772869AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772890AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773583AYA OpticalClaudia Alan IncHOI2025-01-18
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00628120773620AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773835AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773842AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773859AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773873AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773880AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773903AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773910AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
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