Penguin RFA

Basic Information

• Brand Name: Penguin RFA
• Primary DI: 07350096320395
• Version / Model: Penguin RFA Instrument Kit OsseoFuse
• Catalog Number: 55002-O
• Company Name: Integration Diagnostics Sweden AB
• Labeler DUNS: 352736781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-08
• Public Version: 1
• Public Version Date: 2022-03-16
• Public Version Status: New
• Public Device Record Key: c14db6e3-b984-40ef-a94d-7965fc95520f

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36576	Multimeter	A battery-powered electronic instrument intended to be used to measure the amount or strength of values of an electric current, usually voltage and resistance. Sometimes, by means of additional probes, determinations such as sound level, or any form of energy that can be converted into an electrical signal, can be made.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07350096320388	GS1
Primary	07350096320395	GS1