ROMEO 2 PAD INSTRUMENTATION

Basic Information

• Brand Name: ROMEO 2 PAD INSTRUMENTATION
• Primary DI: 07640139349262
• Version / Model: PAD-IN 02 12-N
• Catalog Number: PAD-IN 02 12-N
• Company Name: SpineArt SA
• Labeler DUNS: 483016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 5
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 555f4cd7-31f0-4065-a59c-9b3fc905bd0c

Device Description

Trial Implant Size 12

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: No
• PM Exempt: No
• 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
PEK	Spinous Process Plate	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640139349262	GS1