FDA.reportPublic FDA data

Optego

Primary DI
00360843009975
Brand
Optego
Company
Optego Vision USA Inc.
Model
9350004
Device description
Optego Prism, 4 Diopter
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKTPrism, Fresnel, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKTPrism, Fresnel, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360843009975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360843009975003608430099753608430099750360843009975

GMDN Terms#

Term, Definition table
TermDefinition
Fresnel prismA thin plastic sheet with embossed rulings, which provides the optical effect of a prism, intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction. The device may also be temporarily applied to spectacle lenses to determine how a patient might respond to prismatic power in their eye glasses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
835541145
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00360843006523Optego978369-Optego2023-11-10
00360843006530Optego978369-Optego2023-11-10
00360843009395Optego978362023-11-10
00360843010964Optego98343062024-07-24
00360843010971Optego9827032024-07-24
00360843009142Optego983432024-02-01
00360843009340Optego982702024-01-12
00360843006912Optego9835602024-02-01
00360843006929Optego9835612024-02-01
00360843007247Optego982752024-02-01
00360843009135Optego983392024-02-01
00360843010698Optego983152024-02-01
00360843009364Optego982732024-01-12
00360843007940Optego942882024-01-11
00360843007957Optego942892024-01-11
00360843007964Optego942902024-01-11
00360843007971Optego942912024-01-11
00360843007988Optego942922024-01-11
00360843007995Optego942932024-01-11
00360843008008Optego942942024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00360843009005OptegoOptego Vision USA Inc.HKT2023-08-29
00360843009951OptegoOptego Vision USA Inc.HKT2023-08-29
00360843009968OptegoOptego Vision USA Inc.HKT2023-08-29
00360843009982OptegoOptego Vision USA Inc.HKT2023-08-29
00360843009999OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010001OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010018OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010025OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010032OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010049OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010056OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010063OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010070OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010087OptegoOptego Vision USA Inc.HKT2023-08-29
00360843010094OptegoOptego Vision USA Inc.HKT2023-08-29
00360843009944OptegoOptego Vision USA Inc.HKT2023-08-23
00850029104667FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104674FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104681FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104698FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104704FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104711FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104728FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104735FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104742FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104759FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104766FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104773FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104780FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05
00850029104797FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyHKT2023-02-05