ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180163966
• Version / Model: 23-2021
• Catalog Number: 23-2021
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-21
• Public Version: 1
• Public Version Date: 2023-05-01
• Public Version Status: New
• Public Device Record Key: 883b3130-4eed-497e-a0bf-0aa841e01143

Device Description

Screw Extractor with Speed Lock, 3.95mm - 9.5mm screws, 9.25” (23.5cm) Overall Length, Jaw Width – 11mm, Jaw Length – 5cm

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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44044	Cardiac myoplasty electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be attached to the heart and/or the muscle wrapped around the heart (during myoplasty) to make an electrical connection between the system pulse generator and the muscle(s) to assist the heart in its pumping function.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180163966	GS1

Customer Contacts

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