FDA.reportPublic FDA data

PPT CRYSTALENS 12/BX

Primary DI
04058935000653
Brand
PPT CRYSTALENS 12/BX
Company
Bausch & Lomb GmbH
Model
PPT051
Catalog number
PPT051
Device description
Single Use Medical Device for Ophthalmic Surgery
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058935000653PrimaryGS10
24058935000657Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058935000653040589350006534058935000653
2405893500065724058935000657

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344609518
Device count
12
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058935012779Fogla Trifacet SpatulaE04792025-10-24
04058935012786Fogla Pointed DissectorE04802025-10-24
04058935012809Guide ClaymanE05422025-10-24
04058935012816Hook Lens And Iris SinskeyE05452025-10-24
04058935012823Hook Lens OgawaE05692025-10-24
04058935012830Chopper Spatula NichaminE0570 N2025-10-24
04058935012847Hook Lens Manipulator LesterE05712025-10-24
04058935012854Hook Lens Insertion FenzlE05722025-10-24
04058935012861Chopper Phaco Left NagaharaE0578 L2025-10-25
04058935012878Chopper Phaco Right NagaharaE0578 R2025-10-26
04058935012885Hook Lens MaloneyE05792025-10-26
04058935012892Chopper Ambidextrous SeibelE05902025-10-26
04058935012908Hook Muscle StevensE06002025-10-26
04058935012915Manipulator Nucleus DrysdaleE06292025-10-26
04058935012922Brody Multipurpose ManipulatorE06362025-10-26
04058935012939Spatula Phaco KochE07122025-10-26
04058935012946Snapper Lens ChopperE07292025-10-26
04058935012953Spatula JohnsonE07302025-10-26
04058935012960Chopper Quick-Chop Braga MeleE07562025-10-26
04058935012977Forceps Fixation Curved MoodyE15532025-10-26

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Primary DI, Brand, Company table
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