SILKRO

GUDID 08800016213027

Hironic Co., ltd.

Electrosurgical system

• Primary Device ID: 08800016213027
• NIH Device Record Key: 02b29e3b-ffa5-4c69-806f-0ed2d4bca3e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILKRO
• Version Model Number: SILKRO
• Company DUNS: 557803630
• Company Name: Hironic 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: false
• 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: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com
• Phone: +8215994299
• Email: ocs@hironic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800016213027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210084

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: 2024-07-08
• Device Publish Date: 2024-06-28