NA

Basic Information

• Brand Name: NA
• Primary DI: 00889024374881
• Version / Model: 00-5049-087-00
• Catalog Number: 00-5049-087-00
• Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
• Labeler DUNS: 137354267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-08
• Public Version: 2
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: 2030ddb9-98ee-41c0-a6b4-038ba50bf7fb

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: No
• 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
JDY	EVACUATOR, VAPOR, CEMENT MONOMER	Orthopedic	888.4220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46482	Orthopaedic cement fume evacuator	A mains electricity (AC-powered) portable device designed to filter out and/or evacuate the toxic fumes produced during the preparation of orthopaedic cement [e.g., polymethylmethacrylate (PMMA)] before they can reach the environment. The device is a small enclosure with filters that remove the toxic vapors, diffusing the filtered air in the environment, or that may be connected to the hospital exhaustion system. This device is used mainly in operating rooms and other hospital areas during orthopaedic procedures that involve bone cement preparation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024374881	GS1

Customer Contacts

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