Rumex

Basic Information

• Brand Name: Rumex
• Primary DI: 00840159907634
• Version / Model: 16-0111
• Catalog Number: 16-0111
• Company Name: RUMEX INTERNATIONAL CORP.
• Labeler DUNS: 041546137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-04
• Public Version: 1
• Public Version Date: 2020-06-12
• Public Version Status: New
• Public Device Record Key: b9b996e1-c049-45f7-917c-2a2e3001a2f7

Device Description

Micro Trabeculectomy Punch, 0.60 mm Diameter, 0.30 mm X 0.60 mm Deep Bite, Tip Only

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNJ	Punch, Corneo-Scleral	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13232	Corneoscleral punch	A hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840159907634	GS1