FDA.reportPublic FDA data

FRESNEL PRISM AND LENS

Primary DI
00850029104162
Brand
FRESNEL PRISM AND LENS
Company
Fresnel Prism & Lens Company
Model
4000-5
Catalog number
4000-5
Device description
TRIAL RING - 5 DIOPTER
Published
2021-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPCSet, Lens, Trial, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPCSet, Lens, Trial, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029104162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029104162008500291041628500291041620850029104162

GMDN Terms#

Term, Definition table
TermDefinition
Trial lens setA set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.

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

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
00850029104728FRESNEL PRISM AND LENS3035-F3035-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945BC127680BernellBernellHPC2026-05-03
B945TLRSM0620BernellBernellHPC2026-05-03
B945TLRSM1000BernellBernellHPC2026-05-03
B945TLRSM10000BernellBernellHPC2026-05-03
B945TLRSM10500BernellBernellHPC2026-05-03
B945TLRSM11000BernellBernellHPC2026-05-03
B945TLRSM12000BernellBernellHPC2026-05-03
B945TLRSM1250BernellBernellHPC2026-05-03
B945TLRSM13000BernellBernellHPC2026-05-03
B945TLRSM14000BernellBernellHPC2026-05-03
B945TLRSM1500BernellBernellHPC2026-05-03
B945TLRSM15000BernellBernellHPC2026-05-03
B945TLRSM16000BernellBernellHPC2026-05-03
B945TLRSM1750BernellBernellHPC2026-05-03
B945TLRSM18000BernellBernellHPC2026-05-03
B945TLRSM2000BernellBernellHPC2026-05-03
B945TLRSM20000BernellBernellHPC2026-05-03
B945TLRSM2250BernellBernellHPC2026-05-03
B945TLRSM2500BernellBernellHPC2026-05-03
B945TLRSM2750BernellBernellHPC2026-05-03
B945TLRSM3000BernellBernellHPC2026-05-03
B945TLRSM3250BernellBernellHPC2026-05-03
B945TLRSM3500BernellBernellHPC2026-05-03
B945TLRSM3750BernellBernellHPC2026-05-03
B945TLRSM4000BernellBernellHPC2026-05-03
B945TLRSM4250BernellBernellHPC2026-05-03
B945TLRSM4500BernellBernellHPC2026-05-03
B945TLRSM4750BernellBernellHPC2026-05-03
B945TLRSM5000BernellBernellHPC2026-05-03
B945TLRSM5250BernellBernellHPC2026-05-03