ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00198506042560
• Version / Model: 36-5090
• Catalog Number: 36-5090
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-13
• Public Version: 1
• Public Version Date: 2024-05-21
• Public Version Status: New
• Public Device Record Key: 0c7fcc3e-3ac3-488c-80be-abe24d23b267

Device Description

RAMIREZ STYLE ENDO FOREHEAD SCISSORS-CURVED LEFT WITH DOUBLE ACTION STRAIGHT BLADES, INSULATED SHAFT AND HANDLE WITH RF CONNECTOR, MODULAR 2 - PIECE ROTATABLE 5MM DIA., 5" (12.5CM) WORKING 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: Yes
• 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
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198506042560	GS1

Customer Contacts

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