FDA.reportPublic FDA data

Rexxam

Primary DI
04540008310467
Brand
Rexxam
Company
REXXAM CO., LTD.
Model
TL-35M
Catalog number
TL301
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04540008310467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540008310467045400083104674540008310467

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.

Regulatory Flags#

DUNS number
704538487
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04540008320138RexxamDL-2000 PALJ022026-04-20
04540008320145RexxamDL-2000 SALH022026-04-20
04540008320152RexxamDL-2000 EALG022026-04-20
04540008310030RexxamNVISION-K5001RK3532025-10-17
04540008310320RexxamWAM-5500RK3632025-10-17
04540008310429RexxamDR-900DR-0532025-10-17
04540008310436RexxamACCUREF K-900RK4532025-10-17
04540008310443RexxamACCUREF R-800RE2532025-10-17
04540008310481RexxamTL-34PTL3212025-10-17
04540008310580RexxamLCD-1000PLC2062025-10-17
04540008310603RexxamRET-700RT0032025-10-17
04540008310610RexxamLCD-1000LC2042025-10-17

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