FDA.reportPublic FDA data

MaxField® 100D Slit Lamp Indirect Lens (Blue)

Primary DI
00630238095266
Brand
MaxField® 100D Slit Lamp Indirect Lens (Blue)
Company
OCULAR INSTRUMENTS, INC.
Model
OI-100M/B
Published
2019-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00630238095419Direct MarkingGS10
00630238095266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238095419006302380954196302380954190630238095419
00630238095266006302380952666302380952660630238095266

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046212387
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630238081795MaxLight® Standard 90D Slit Lamp Indirect Lens (Green)OI-STD/GN2019-06-11
00630238007122Ritch Trabeculoplasty Laser LensORTA7122019-06-12
0063023812224513063 RxSight 0.766x Mag Contact Lens130632019-09-11
00630238084741MaxAC® Lens StandOI-LSA2019-06-11
00063023800712Ritch Trabeculoplasty Laser LensORTA2019-06-12
00630238006972Koeppe Extra Small Diagnostic Lens 12mm O.D. OKES-122019-06-12
00630238007092Single Mirror Kaufman Laser LensOKSMA2019-06-12
00630238008075Koeppe Large Diagnostic Lens 19mm O.D.OKL2019-06-12
00630238008099Koeppe Medium Diagnostic Lens 18mm O.D.OKM2019-06-12
00630238008105Koeppe Small Diagnostic Lens 17mm O.D.OKS2019-06-12
00630238008549Koeppe Extra Small Diagnostic Lens 16mm O.D.OKES-162019-06-12
00630238009973Landers Lens ForcepsOLV-FCP2019-06-12
00630238041072Koeppe Extra Small Diagnostic Lens 14mm O.D.OKES-142019-06-12
00630238056656Handle For Vitrectomy LensesOLIV-H2019-06-12
00630238077255Landers Short Two Strut Vitrectomy Lens RingOLVR-S2S2019-06-12
00630238077330Landers Short Notched Vitrectomy Lens RingOLVR-S3N2019-06-12
00630238108201Glaukos® iprism® (Left-Handed)OTB/LH-22019-06-12
00630238108256Glaukos® iprism® (Right-Handed)OTB/RH-22019-06-12
00630238113465Reichel OCT SteadyEyeOROCTS2019-06-12
00630238118903Upright 1.3x Surgical Gonio LensOUSG-1.3X2019-06-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081160801981920D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
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