FDA.reportPublic FDA data

Lee-Mainster SLO 60-2 Retina Lens

Primary DI
00630238088206
Brand
Lee-Mainster SLO 60-2 Retina Lens
Company
OCULAR INSTRUMENTS, INC.
Model
OSLO60-2
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJLLens, Condensing, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630238088794Direct MarkingGS10
00630238088206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238088794006302380887946302380887940630238088794
00630238088206006302380882066302380882060630238088206

GMDN Terms#

Term, Definition table
TermDefinition
Hruby fundus lensA 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046212387
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630238009973Landers Lens ForcepsOLV-FCP2019-06-12
00630238056656Handle For Vitrectomy LensesOLIV-H2019-06-12
00630238084741MaxAC® Lens StandOI-LSA2019-06-11
00630238095235MaxField® 100D Slit Lamp Indirect Lens (Green)OI-100M/GN2019-06-10
00630238081795MaxLight® Standard 90D Slit Lamp Indirect Lens (Green)OI-STD/GN2019-06-11
00630238049023Ultra View Small Pupil Slit Lamp Binocular Indirect LensOI-SP2019-06-11
00630238077422MaxAC® 20D Binocular Indirect LensOI-20A2019-06-11
00630238077491MaxAC® 28D Binocular Indirect LensOI-28A2019-06-11
00630238081658MaxField® Standard 90D Slit Lamp Indirect Lens (Red)OI-STDM/R2019-06-11
00630238082082MaxLight® Standard 90D Slit Lamp Indirect Lens (Red)OI-STD/R2019-06-11
00630238082983MaxLight® High Mag 78D Slit Lamp Indirect Lens (Purple)OI-HM/P2019-06-11
00630238083058MaxLight® High Mag 78D Slit Lamp Indirect Lens (Gold)OI-HM/GD2019-06-11
00630238083331MaxField® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Purple)OI-STDM-LR/P2019-06-11
00630238085113MaxField® High Mag 78 Slit Lamp Indirect Lens (Purple)OI-HM-78M/P2019-06-11
00630238085144MaxField® High Mag 78 Slit Lamp Indirect Lens (Red)OI-HM-78M/R2019-06-11
00630238092647MaxField® 22D Binocular Indirect Lens (Blue)OI-22M/B2019-06-11
00630238096959Saxena Retinal Grid 520OI-SRG5202019-06-11
00630238099073MaxLight® 18D Binocular Indirect Lens (Green)OI-18/GN2019-06-11
00630238099325MaxField® 18D Binocular Indirect Lens (Green)OI-18M/GN2019-06-11
00630238099332MaxField® 18D Binocular Indirect Lens (Purple)OI-18M/P2019-06-11

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Primary DI, Brand, Company table
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0081160801982628D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801984078D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801985790D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019864Super 66® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019871SuperField® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019888Digital Wide Field® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801476020D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801477728D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014784Pan Retinal 2.2 Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014791Digital ClearField Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801480778D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801481490D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014821Super 66® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014838SuperField® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014845Digital Wide Field® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014852Digital High Mag® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00841668144268Primary Lens Set, 28D, 90D, 3 MirrorKATENA PRODUCTS, INC.HJL2024-04-11
00841668144275Primary Lens Set, 28D, 90D, 4 MirrorKATENA PRODUCTS, INC.HJL2024-04-11
00850054345004eZView 125Ion Vision, IncHJL2023-08-23
00850054345011eZView 20DIon Vision, IncHJL2023-08-23
00850054345028SurgiView 20DIon Vision, IncHJL2023-08-23
00850054345035eZView 90DIon Vision, IncHJL2023-08-23
00850054345042eZView 78DIon Vision, IncHJL2023-08-23
00850054345059eZView 60DIon Vision, IncHJL2023-08-23
00850054345066eZView 15DIon Vision, IncHJL2023-08-23
00850054345073eZView 25DIon Vision, IncHJL2023-08-23
00850054345080eZView 28DIon Vision, IncHJL2023-08-23