NA

Basic Information

• Brand Name: NA
• Primary DI: 10603295174516
• Version / Model: 5461-26-000
• Catalog Number: 546126000
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Labeler DUNS: 080506581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: e7964c4a-2dc4-408a-ab25-de2423a6cd18

Device Description

FEMORAL PRESSURIZER

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIH	DISPENSER, CEMENT	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46031	Orthopaedic cement compressor	A device used to apply pressure to orthopaedic bone cement during a total hip arthroplasty (THA) procedure (within the acetabulum and/or femur) in order to optimise inner bone (cancellous) cement interdigitation to improve fixation of the implant. The device is typically made of a compressible silicone rubber which conforms to the shape of the cut bone to enable formation of a good seal. Cement may be injected through the device into the bone cavity using an appropriate syringe; pressure may be applied to the device with a firm handle (e.g., stainless steel), or a backplate. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295174516	GS1

Customer Contacts

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