Medetz Surgical Instruments

Basic Information

• Brand Name: Medetz Surgical Instruments
• Primary DI: G223IAT3CVD0
• Version / Model: iat-.3-cvd
• Company Name: Medetz Surgical Instruments LLC
• Labeler DUNS: 876570990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-10
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: 81434a4d-433b-401f-b90c-655dde00b825

Device Description

I/A Curved Tip ONLY, 16ga Outer Sleeve, 21ga Closed Inner Cannula tip with .3mm Aspirating Port, 20mm Curved Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length

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
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	886.4360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G223IAT3CVD0	HIBCC

Customer Contacts

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