miLOOP reusable

Basic Information

• Brand Name: miLOOP reusable
• Primary DI: 00850005541073
• Version / Model: FG-50896
• Company Name: Carl Zeiss Meditec, Cataract Technology, Inc.
• Labeler DUNS: 080125056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 2
• Public Version Date: 2025-04-04
• Public Version Status: Update
• Public Device Record Key: 770433c2-5462-4050-a59a-3fd1f77e7682

Device Description

Ophthalmic Instrument. Lens Fragmentation Device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
62469	Ophthalmic soft-tissue manipulation forceps, probe-like, reusable	A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30850005541074	GS1	Cardboard	4	In Commercial Distribution
Primary	00850005541073	GS1
Unit of Use	10850005541070	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]