HAND PIECE

GUDID 08809502330446

VIOL Co.,Ltd.

Electrosurgical system

• Primary Device ID: 08809502330446
• NIH Device Record Key: f563fa1b-567a-4346-828f-b2054f35fae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAND PIECE
• Version Model Number: H/S_03
• 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	08809502330446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180872

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: 2025-07-21
• Device Publish Date: 2025-07-11

On-Brand Devices [HAND PIECE]

• 08809502330040: H/S_02
• 08809502330446: H/S_03