Medetz Surgical Instruments

Basic Information

• Brand Name: Medetz Surgical Instruments
• Primary DI: G223140200700
• Version / Model: 14-0200-7.0
• Company Name: Medetz Surgical Instruments LLC
• Labeler DUNS: 876570990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-05
• Public Version: 1
• Public Version Date: 2025-11-13
• Public Version Status: New
• Public Device Record Key: 25a4523b-c92b-4c64-b330-710ce927b4df

Device Description

Camellin Style LASEK 7.0mm Alcohol Well, Flat Handle, Stainless Steel

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: No
• 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
HNB	Spoon, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63523	LASEK alcohol well, reusable	A hand-held, manual, ophthalmic surgical device designed to hold a small reservoir of alcohol solution at the surface of the cornea to soften the corneal epithelium for subsequent epithelial flap creation during laser-assisted epithelial keratomileusis (LASEK) surgery. It may additionally be designed to hold/assist placement of the dedicated trephine (cylindrical cutting blade) at the surface of the eye during flap creation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G223140200700	HIBCC

Customer Contacts

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