ELMED INCORPORATED

Basic Information

• Brand Name: ELMED INCORPORATED
• Primary DI: 00198506073748
• Version / Model: 40-5406
• Catalog Number: 40-5406
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-19
• Public Version: 1
• Public Version Date: 2024-12-27
• Public Version Status: New
• Public Device Record Key: e9bbd98f-bbce-4499-8e89-cd2262a417f7

Device Description

JACKSON ALLIGATOR GRASPING FORCEP, 4MM X 22MM JAW, 60CM WORKING LENGTH, FOR USE THROUGH SCOPE 6.0MM OR LARGER. AUTOCLAVABLE MEDICAL GRADE STAINLESS STEEL.

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: Yes
• 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	00198506073748	GS1

Customer Contacts

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