MR PHACO

Basic Information

• Brand Name: MR PHACO
• Primary DI: G412PH9503T0
• Version / Model: PH9503T
• Company Name: Crestpoint Management Limited
• Labeler DUNS: 836285668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-07
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: 296319a8-6c89-4422-a15c-ba5e9d9f67d8

Device Description

Globe Fixation Ring Fixed, 16mm OD x 12mm ID, C-Style Head, Fine concentric grooves, Round Knurled Handle, 110mm Overall Length, Titanium

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
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32758	Flieringa ophthalmic ring	A circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G412PH9503T0	HIBCC