FDA.reportPublic FDA data

Capsule Polishing Curette

Primary DI
00840096205848
Brand
Capsule Polishing Curette
Company
KATALYST SURGICAL LLC
Model
1601
Device description
Capsule Polishing Curette
Published
2020-05-14
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
00840096205848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096205848008400962058488400962058480840096205848

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, reusableA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. 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
10817489027483Laser Probe OS4, MultiFlex, 23gaVK4003032019-03-19
10817489027490Laser Probe OS4, MultiFlex, 25gaVK4003052019-03-19
10817489027506Laser Probe OS4, MultiFlex Inverted, 23gaVK4003132019-03-19
10817489027513Laser Probe OS4, MultiFlex Inverted, 25gaVK4003152019-03-19
10817489027520Laser Probe OS4, MultiFlex Extendable, 23gaVK4003232019-03-19
10817489027544Laser Probe OS4, MultiFlex Inverted Extendable, 23gaVK4003332019-03-19
10817489027551Laser Probe OS4, MultiFlex Inverted Extendable, 25gaVK4003352019-03-19
1084009621123520ga Straight Laser Probe6202002020-03-04
1084009621124223ga Straight Laser Probe6202012020-03-04
1084009621125925ga Straight Laser Probe6202022020-03-04
1084009621126627ga Straight Laser Probe6202032020-03-04
1084009621127323ga Flexible Curved Laser Probe6202102020-03-04
1084009621128025ga Flexible Curved Laser Probe6202112020-03-04
1084009621129727ga Flexible Curved Laser Probe6202122020-03-04
1084009621130320ga Illuminated Straight Laser Probe6202202020-03-04
1084009621131023ga Illuminated Straight Laser Probe6202212020-03-04
1084009621132725ga Illuminated Straight Laser Probe6202222020-03-04
1084009621133427ga Illuminated Straight Laser Probe6202232020-03-04
1084009621134123ga Illuminated Flexible Curved Laser Probe6202292020-03-04
1084009621135825ga Illuminated Flexible Curved Laser Probe6202302020-03-04

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