FDA.reportPublic FDA data

FRESNEL PRISM AND LENS

Primary DI
00850029104728
Brand
FRESNEL PRISM AND LENS
Company
Fresnel Prism & Lens Company
Model
3035-F
Catalog number
3035-F
Device description
FRESNEL LENS, D-SEGMENT, 3.5 DIOPTER
Published
2023-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00850029104728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029104728008500291047288500291047280850029104728

GMDN Terms#

Term, Definition table
TermDefinition
Fresnel lensA very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions including aphakia (absence of the lens of the eye), myopia, hyperopia, and presbyopia. It is typically made of glass or plastic and its surface is a concentric series of increasingly refractive zones.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE, AVOID EXESSIVE HEAT AND HUMIDITY

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-496-0432info@fresnelprism.com

Regulatory Flags#

DUNS number
789337987
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
00850029104025MYI OCCLUSION EYE PATCHES0092021-03-29
00850029104032MYI OCCLUSION EYE PATCHES0102021-03-29
00850029104117VISION SCREENING PATCH5110B5110B2021-03-29
00850029104001MYI OCCLUSION EYE PATCHES0082021-03-29
00850029104018MYI OCCLUSION EYE PATCHES0072021-03-29
00850029104049COVERCLUDE OCCLUSION EYE PATCHES0112021-03-29
00850029104056COVERCLUDE OCCLUSION EYE PATCHES0122021-03-29
00850029104124VISION SCREENING PATCHIND5110B2021-03-29
00850029104650FRESNEL PRISM AND LENS6300-B6300-B2023-02-05
00850029104667FRESNEL PRISM AND LENS3005-F3005-F2023-02-05
00850029104674FRESNEL PRISM AND LENS3010-F3010-F2023-02-05
00850029104681FRESNEL PRISM AND LENS3015-F3015-F2023-02-05
00850029104698FRESNEL PRISM AND LENS3020-F3020-F2023-02-05
00850029104704FRESNEL PRISM AND LENS3025-F3025-F2023-02-05
00850029104711FRESNEL PRISM AND LENS3030-F3030-F2023-02-05
00850029104735FRESNEL PRISM AND LENS3040-F3040-F2023-02-05
00850029104742FRESNEL PRISM AND LENS3060-F3060-F2023-02-05
00850029104759FRESNEL PRISM AND LENS3080-F3080-F2023-02-05
00850029104766FRESNEL PRISM AND LENS3100-F3100-F2023-02-05
00850029104773FRESNEL PRISM AND LENS3120-F3120-F2023-02-05

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
00360843009975OptegoOptego 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
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