CELFIRM

GUDID 08809502330026

VIOL Co.,Ltd.

Electrosurgical system

• Primary Device ID: 08809502330026
• NIH Device Record Key: 1b4716ad-0e49-48b1-a930-bc3bf098c7b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELFIRM
• Version Model Number: CELFIRM
• Company DUNS: 695654949
• Company Name: VIOL 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809502330026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172023

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: 4
• Public Version Date: 2021-01-15
• Device Publish Date: 2018-02-23

Devices Manufactured by VIOL Co.,Ltd.

• 08809502330422 - SCARLET PRO: 2025-07-21
• 08809502330439 - FOOT SWITCH: 2025-07-21
• 08809502330446 - HAND PIECE: 2025-07-21
• 08809502330286 - CELLINEW Foot switch: 2024-12-17
• 08809502330347 - CELLINEW: 2024-12-17
• 08809502330361 - CELLINEW Handpiece: 2024-12-17
• 08809502330378 - CELLINEW TIP: 2024-12-17
• 08809502330385 - CELLINEW TIP: 2024-12-17