UCP Stem

Basic Information

• Brand Name: UCP Stem
• Primary DI: 04719886891010
• Version / Model: 9107-6000-RA
• Catalog Number: 9107-6000-RA
• Company Name: UNITED ORTHOPEDIC CORP.
• Labeler DUNS: 656700556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-02
• Public Version: 1
• Public Version Date: 2022-11-10
• Public Version Status: New
• Public Device Record Key: caa3c80e-0e30-4afc-ab32-188f77e69a8d

Device Description

UCP Stem broach, #0

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: Yes
• PM Exempt: Yes
• 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
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	888.3353	2
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	888.3350	2
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	888.3360	2
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	888.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719886891010	GS1

Customer Contacts

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