Fraxis Duo ARM

GUDID 08800023200027

FRX 2.0 Articualed Arm

ILOODA.CO.,LTD

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 08800023200027
• NIH Device Record Key: ddacbc64-b893-4f11-9318-01be072b1581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fraxis Duo ARM
• Version Model Number: FRX 2.0 Articualed Arm
• Company DUNS: 631129749
• Company Name: ILOODA.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023200027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160312

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-12-16

Devices Manufactured by ILOODA.CO.,LTD

• 08800023200942 - Secret DUO Main Unit: 2023-09-07
• 08800023200959 - Secret DUO Standard Handpiece: 2023-09-07
• 08800023201239 - Secret DUO Bigger Handpiece: 2023-09-07
• 08800023201390 - Secret DUO Laser Handpiece: 2023-09-07
• 08800023202168 - reepot Main Unit: 2023-09-07
• 08800023202175 - reepot Handpiece: 2023-09-07
• 08800023200218 - VIKINI Main Unit: 2023-06-19
• 08800023200225 - VIKINI Laser H/P: 2023-06-19 DET Laser H/P