FDA.reportPublic FDA data

BK S2 B, without convex cylinders, wooden case with handle

Primary DI
04049584001658
Brand
BK S2 B, without convex cylinders, wooden case with handle
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
334912
Device description
BK S2 B, without convex cylinders, wooden case with handle
Published
2022-12-08
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
04049584001658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584001658040495840016584049584001658

GMDN Terms#

Term, Definition table
TermDefinition
Trial lens frameA device used in ophthalmic work for placing, holding, and exchanging trial lenses in front of the eyes of the patient during a sight-testing procedure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

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