FDA.report

MaxField® 66D Slit Lamp Indirect Lens (Purple)

Primary DI
00630238094498
Brand
MaxField® 66D Slit Lamp Indirect Lens (Purple)
Company
OCULAR INSTRUMENTS, INC.
Model
OI-66M/P
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

Related Records

Product Codes

CodeName
HJLLens, Condensing, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630238094597Direct MarkingGS10
00630238094498PrimaryGS10

GMDN Terms

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

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

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00063023800712Ritch Trabeculoplasty Laser LensORTA2019-06-12
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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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