CONSUMABLE TIP

GUDID 28809502330013

Viol Co., Ltd.

Electrosurgical system

• Primary Device ID: 28809502330013
• NIH Device Record Key: 9eb60017-bc28-45cf-ad55-45e593e99edf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSUMABLE TIP
• Version Model Number: Consumable Tip
• Company DUNS: 557821797
• Company Name: Viol Co., Ltd.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08809502330019 [Unit of Use]
GS1	28809502330013 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-09-18
• Device Publish Date: 2018-02-23

On-Brand Devices [CONSUMABLE TIP]

• 38809502330010: Consumable Tip
• 28809502330013: Consumable Tip