FDA.report

MR PHACO

Primary DI
G412PH85012T0
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH85012T
Device description
"I/A 150 Degree Tip ONLY, 16ga Outer Sleeve, 21ga Inner Cannula tip with .5mm open front port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Titanium with Stainless Inner Tube Please note: Once engraved, this item CANNOT be returned unless there was a manufacturing defect"
Published
2025-05-30
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

Related Records

Product Codes

CodeName
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G412PH85012T0PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
836285668
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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