FDA.reportPublic FDA data

TS75 Trial Lens

Primary DI
00812559010566
Brand
TS75 Trial Lens
Company
REICHERT, INC.
Model
15015
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00812559010566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559010566008125590105668125590105660812559010566

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

Regulatory Flags#

DUNS number
126650253
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
00812559010580PDM Digital PD Meter150202025-08-12
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12
00812559011730Phoropter VRx162422025-08-12

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