MR PHACO

Basic Information

• Brand Name: MR PHACO
• Primary DI: G412PH6009L0
• Version / Model: PH6009L
• Company Name: Crestpoint Management Limited
• Labeler DUNS: 836285668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-02
• Public Version: 1
• Public Version Date: 2025-06-10
• Public Version Status: New
• Public Device Record Key: 6a94b924-5512-4fc5-9c9d-b4fd2d058ba4

Device Description

Nagahara-Fine Phaco Chopper Fine Interior Cutting Edge with Blunt tip, Angled 10mm from bend to tip, for use in the RIGHT HAND, Round Knurled Handle, 115mm Overall Length, Stainless Steel

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNQ	Hook, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G412PH6009L0	HIBCC