ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180148840
• Version / Model: 23-S0129
• Catalog Number: 23-S0129
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-13
• Public Version: 1
• Public Version Date: 2023-03-21
• Public Version Status: New
• Public Device Record Key: e5dc21d4-1d7b-4c69-af48-2ec1b8e969eb

Device Description

Fracture Reduction Pick, Overall Length: 6.25" (15,9 cm)

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: No
• 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
64024	Tissue pick	A hand-held manual surgical instrument designed primarily to hook/grasp skin to lift the skin and adjacent tissues during a surgical intervention. It is a shaft-like metallic instrument with a proximal handle and two small opposing (i.e., curved in opposite directions) sharp hooks at the distal end. When the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180148840	GS1

Customer Contacts

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