CONFIDENCE SPINAL CEMENT SYSTEM

Basic Information

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
• Primary DI: 10705034209395
• Version / Model: 283901915
• Catalog Number: 283901915
• Company Name: DEPUY SPINE, LLC
• Labeler DUNS: 107105876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 3
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 0fed8fae-2c78-4a4c-9bf1-e33d00502cd9

Device Description

CONFIDENCE SPINAL CEMENT SYSTEM BIOPSY NEEDLE 15G x 9 Inches

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
MJG	DEVICE, PERCUTANEOUS, BIOPSY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705034209395	GS1

Customer Contacts

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