Rumex

Basic Information

• Brand Name: Rumex
• Primary DI: 00840159909201
• Version / Model: 13-163
• Catalog Number: 13-163
• 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: 30793465-366c-485f-97c2-a7416cd9edc2

Device Description

Helveston Tissue Retractor, Thin Curved Blade, "Barbie" 7.00 mm Wide

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
HNI	Retractor, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63431	Intraocular retractor, reusable	A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840159909201	GS1