FDA.reportPublic FDA data

Ultra View Small Pupil Slit Lamp Binocular Indirect Lens

Primary DI
00630238049023
Brand
Ultra View Small Pupil Slit Lamp Binocular Indirect Lens
Company
OCULAR INSTRUMENTS, INC.
Model
OI-SP
Published
2019-06-11
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
00630238067669Direct MarkingGS10
00630238049023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238067669006302380676696302380676690630238067669
00630238049023006302380490236302380490230630238049023

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
046212387
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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
00630238100588Saxena Retinal Grid 428OI-SRG4282019-06-11

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Primary DI, Brand, Company table
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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