SYLFIRM X

GUDID 08809502330101

Viol Co., Ltd.

Electrosurgical system

• Primary Device ID: 08809502330101
• NIH Device Record Key: edf19c12-f29b-48d8-8a4c-392a89cf5103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYLFIRM X
• Version Model Number: SYLFIRM X
• Company DUNS: 557821797
• 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	08809502330101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200185

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-05-06
• Device Publish Date: 2020-04-28

Devices Manufactured by Viol Co., Ltd.

• 08809502330101 - SYLFIRM X: 2020-05-06
• 08809502330101 - SYLFIRM X: 2020-05-06
• 38809502330010 - CONSUMABLE TIP: 2018-10-18
• 28809502330013 - CONSUMABLE TIP: 2018-09-18