FDA.reportPublic FDA data

23ga Carbon Fiber Capsule Polisher

Primary DI
00840096206524
Brand
23ga Carbon Fiber Capsule Polisher
Company
KATALYST SURGICAL LLC
Model
4399-23
Device description
23ga Carbon Fiber Capsule Polisher
Published
2020-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096206524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096206524008400962065248400962065240840096206524

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic working-channel cannula, reusableA rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1081748902630125ga DEX™ Slim Morris ILM ForcepsDVFO4033-25DVFO4033-252020-09-21
1081748902631827ga DEX™ Stiff Slim Morris ILM ForcepsDVFO4033-27DVFO4033-272020-09-21
1081748902714823ga DEX™ Hassan ForcepsDVF4035-23DVF4035-232020-11-01
1081748902716227ga DEX Stiff Hassan ForcepsDVF4035-27DVF4035-272020-11-01
1081748902731523ga Slim DEX™ Hassan ForcepsDVFO4035-23DVFO4035-232020-09-21
1081748902732225ga Slim DEX™ Hassan ForcepsDVFO4035-25DVFO4035-252020-09-21
1081748902733927ga Stiff Slim DEX™ Hassan ForcepsDVFO4035-27DVFO4035-272020-09-21
1081748902735327ga Slim DEX™ Vertical ScissorsDVSO5101-272020-11-01
1081748902739123ga MultiFlex Laser Probe, Iridex CompatibleXLEND23MULTIFLEXAXLEND23MULTIFLEXA2018-11-26
1084009621104423ga Slim DEX™ Super Grip II ForcepsDVFO4036-23DVFO4036-232020-09-21
1084009621110525ga Slim DEX™ Super Grip II ForcepsDVFO4036-25DVFO4036-252020-09-21
1084009621111227ga Stiff Slim DEX™ Super Grip II ForcepsDVFO4036-27DVFO4036-272020-09-21
1084009621117425ga Stiff DEX™ Yoneda Super Grip ForcepsDVF4036-25-SDVF4036-25-S2020-11-01
1084009621289823ga DEX™ EZPeel ForcepsDVF4037-23DVF4037-232020-07-06
1084009621290425ga DEX™ EZPeel ForcepsDVF4037-25DVF4037-252020-07-06
1084009621291127ga DEX™ EZPeel ForcepsDVF4037-27DVF4037-272020-07-06
1084009621292825ga Stiff DEX™ EZPeel ForcepsDVF4037-25-SDVF4037-25-S2020-07-06
1084009621293523ga Slim DEX™ EZPeel ForcepsDVFO4037-23DVFO4037-232020-07-06
1084009621294225ga Slim DEX™ EZPeel ForcepsDVFO4037-25DVFO4037-252020-07-06
1084009621295925ga Slim Stiff DEX™ EZPeel ForcepsDVFO4037-25-SDVFO4037-25-S2020-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047923630Kratz Capsule PolisherA1 Medical GmbHMXY2026-05-29
00757770701216Bausch + LombBausch & Lomb IncorporatedMXY2025-11-16
00757770701223Bausch + LombBausch & Lomb IncorporatedMXY2025-11-16
00757770446995Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770494156Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770505746Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770505845Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00194613002541MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002558MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002572MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002602MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613003067MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613083908MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613105488MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00757770509188Bausch + LombBausch & Lomb IncorporatedMXY2025-07-29
00757770510672Bausch + LombBausch & Lomb IncorporatedMXY2025-07-29
00194613002596MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613002633MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613003081MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613018290MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2024-08-15
G223119400D0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCMXY2023-09-25
00840516116907Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116914Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116921Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116938Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116945Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116952Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116969Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116976Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116983Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30