FDA.reportPublic FDA data

Lorgnette with striated lenses (Bagolini), Axes 45°/123°

Primary DI
04049584005878
Brand
Lorgnette with striated lenses (Bagolini), Axes 45°/123°
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
42770
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPDLens, Bagolini

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPDLens, BagoliniOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584005878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584005878040495840058784049584005878

GMDN Terms#

Term, Definition table
TermDefinition
Bagolini lens/spectacles/lorgnetteAn ophthalmic device in the form of a separate lens, spectacles or lorgnette intended to be used to determine/diagnose ophthalmic conditions (e.g., pseudofovea, abnormal retinal correspondence, suppression and diplopia). The lens has narrow striations running parallel in one meridian and can be used in a trial lens frame, or fixed in a spectacles/lorgnette frame, for binocular testing. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
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