Rumex

Basic Information

• Brand Name: Rumex
• Primary DI: 00840159903308
• Version / Model: 16-111
• Catalog Number: 16-111
• Company Name: RUMEX INTERNATIONAL CORP.
• Labeler DUNS: 041546137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 2e8998e7-e78e-48c2-8a44-25b0f6750cc1

Device Description

Schocket Double Ended Scleral Depressor, With pocket clip, Length 130 mm, Round Titanium Handle

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
HNX	Depressor, Orbital	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16465	Orbital depressor, reusable	A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840159903308	GS1