DFINE®

Basic Information

• Brand Name: DFINE®
• Primary DI: 00884450296400
• Version / Model: 00884450296400
• Catalog Number: 3610/A
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-03
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 79d0acb0-b94d-4e01-a9c3-7ee5db8ce3af

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDN	CEMENT, BONE, VERTEBROPLASTY	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62393	Orthopaedic cement dispensing controller	A mains electricity (AC-powered), electromechanical, bench-top unit designed to drive orthopaedic bone cement through a connected hydraulic cement dispensing device (e.g., syringe, dispensing gun) during arthroplastic/osteosynthetic procedures (e.g., vertebroplasty, kyphoplasty). It may additionally be intended to regulate the temperature of the cement to help modulate its viscosity during delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450296407	GS1		1	In Commercial Distribution
Primary	00884450296400	GS1

Premarket Submissions

Submission Number	Supplement Number
K090986	000