FDA.reportPublic FDA data

Peyman-Wessels-Landers 132D Upright Vitrectomy Lens

Primary DI
00630238078368
Brand
Peyman-Wessels-Landers 132D Upright Vitrectomy Lens
Company
OCULAR INSTRUMENTS, INC.
Model
OUV-132-2
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
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630238077798Direct MarkingGS10
00630238078368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238077798006302380777986302380777980630238077798
00630238078368006302380783686302380783680630238078368

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, reusableA non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.

Sterilization Methods#

Method table
Method
High-level Disinfectant

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
true

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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