ROMEO 2 PAD INSTRUMENTATION

Basic Information

• Brand Name: ROMEO 2 PAD INSTRUMENTATION
• Primary DI: 07640139349309
• Version / Model: PAD-IN 05 00-N
• Catalog Number: PAD-IN 05 00-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: 3
• Public Version Date: 2018-08-01
• Public Version Status: Update
• Public Device Record Key: 9a5d6160-bd54-4daf-ae67-7f31a80652f0

Device Description

Compactor

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
47743	Bone graft packing block	A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640139349309	GS1