Alcon

Primary DI
00749590397168
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
749590397168
Device description
Hand-held optical device placed in front of the eyes to aid vision testing.
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPAFrame, trial, ophthalmic
HPCSet, lens, trial, ophthalmic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749590397168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749590397168007495903971687495903971680749590397168

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training flipperA device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

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