N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00889024433083
• Version / Model: 5069-61
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b0b54265-4fde-419c-ae37-d2f7be6f460e
• Distribution End Date: 2017-05-26

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KIH	DISPENSER, CEMENT	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024433083	GS1

Customer Contacts

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