FDA.reportPublic FDA data

MR PHACO

Primary DI
G412CA11850
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
CA1185
Device description
McIntyre Straight Outer Cannula 19ga Straight Shaft with Blunt Tip, 17.5mm Overall Length
Published
2025-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G412CA11850PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
836285668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G412CA11700MR PHACOCA11702025-06-09
G412DK70030MR PHACODK70032025-06-09
G412MMP2480MR PHACOMMP2482025-06-09
G412PH10200MR PHACOPH10202025-06-09
G412PH10270MR PHACOPH10272025-06-09
G412PH19980MR PHACOPH19982025-06-09
G412PH20310MR PHACOPH20312025-06-09
G412PH21080MR PHACOPH21082025-06-09
G412PH21190MR PHACOPH21192025-06-09
G412PH22050MR PHACOPH22052025-06-09
G412PH22060MR PHACOPH22062025-06-09
G412PH22180MR PHACOPH22182025-06-09
G412PH227410MR PHACOPH2274-12025-06-09
G412PH22780MR PHACOPH22782025-06-09
G412PH62530MR PHACOPH62532025-06-09
G412PH94030MR PHACOPH94032025-06-09
G412PH94071T0MR PHACOPH94071T2025-06-09
G412PH9408T0MR PHACOPH9408T2025-06-09
G412PH95400MR PHACOPH95402025-06-09
G412PH98270MR PHACOPH98272025-06-09

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Primary DI, Brand, Company table
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B382S347891000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891190Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347911020Surgical DirectSurgical Direct, Inc.HMX2026-07-31
G223140190270Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-07-27
00190776403843MillenniumAvalign Technologies, Inc.HMX2026-07-21
00190776400569MillenniumAvalign Technologies, Inc.HMX2026-07-19
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
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04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
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04251047915086Akahoshi Combo Pre-ChopperA1 Medical GmbHHMX2026-05-29
04251047923296Rycroft Air Injection CannulaA1 Medical GmbHHMX2026-05-29
04251047923388Sauter Hydrodissection CannulaA1 Medical GmbHHMX2026-05-29
04251047933295Gerten Clear Cornea DALK CannulaA1 Medical GmbHHMX2026-05-29
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08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
07612717072091FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072107FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26