miLOOP

Basic Information

• Brand Name: miLOOP
• Primary DI: 00860000122306
• Version / Model: 104
• Company Name: Carl Zeiss Meditec, Cataract Technology, Inc.
• Labeler DUNS: 080125056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-02-12
• Public Version: 4
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: 56f3ad01-82cf-4543-9a7d-54ce61383e4e

Device Description

Ophthalmic Instrument. Lens Fragmentation Device.

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
62478	Ophthalmic soft-tissue manipulation forceps, probe-like, single-use	A sterile, 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 grasping blades that protrude from the distal end of the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30860000122307	GS1	Corrugated Cardboard	6	In Commercial Distribution
Primary	00860000122306	GS1
Unit of Use	10860000122303	GS1

Customer Contacts

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