Penguin RFA 55002

GUDID 07350096320012

Integration Diagnostics Sweden AB

Multimeter

• Primary Device ID: 07350096320012
• NIH Device Record Key: 17487484-f6f9-4a16-9e8b-339c58132e32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penguin RFA
• Version Model Number: Penguin RFA Instrument Kit
• Catalog Number: 55002
• Company DUNS: 352736781
• Company Name: Integration Diagnostics Sweden AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350096320012 [Direct Marking]
GS1	07350096320081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143445

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Penguin RFA]

• 07350096320029: Penguin RFA Instrument Kit Neoss
• 07350096320036: Penguin RFA Instrument Kit Implant Swiss
• 07350096320012: Penguin RFA Instrument Kit
• 07350096320388: Penguin RFA Instrument Kit OsseoFuse
• 07350096320296: Penguin RFA Instrument Kit SIC
• 07350096320203: IS3 Instrument Kit
• 07350096320197: Penguin RFA Instrument Kit Bredent
• 07350096320067: Penguin RFA Instrument Kit Citagenix
• 07350096320050: Penguin RFA Instrument Kit Klockner Black
• 07350096320043: Penguin RFA Instrument Kit Klockner White