FDA.reportPublic FDA data

MaxAC® Lens Stand

Primary DI
00630238084741
Brand
MaxAC® Lens Stand
Company
OCULAR INSTRUMENTS, INC.
Model
OI-LSA
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
00630238084727Direct MarkingGS10
00630238084741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238084727006302380847276302380847270630238084727
00630238084741006302380847416302380847410630238084741

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

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
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
00630238100588Saxena Retinal Grid 428OI-SRG4282019-06-11

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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
00850054345097SurgiView 28DIon Vision, IncHJL2023-08-23