ELMED INCORPORATED

Basic Information

• Brand Name: ELMED INCORPORATED
• Primary DI: 00198506074745
• Version / Model: 232 412-09
• Catalog Number: 232 412-09
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-27
• Public Version: 1
• Public Version Date: 2025-02-04
• Public Version Status: New
• Public Device Record Key: 2387b031-ae48-4592-b9e9-39466c5993b8

Device Description

JUMBO MAYO STAND PART: FASTENING KNOB FOR UPPER TRAY ROTATION

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
LRP	Tray, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61454	Surgical tray stand	A mobile, freestanding device intended to be used during a surgical procedure onto/into which a surgical tray (e.g., surgical sponge-counting tray) can be placed. It consists of a metal vertical upright on a wheeled base with a top surface that may allow for integration of dedicated surgical trays. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198506074745	GS1

Customer Contacts

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