Handlike

GUDID 06957270301549

Hunan Handlike Minimally Invasive Surgery Co., Ltd.

Soft-tissue ultrasonic surgical system

• Primary Device ID: 06957270301549
• NIH Device Record Key: 5b224685-3d1b-4650-9b51-d18d76606e3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handlike
• Version Model Number: HD-CSXT-001
• Company DUNS: 544338343
• Company Name: Hunan Handlike Minimally Invasive Surgery 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06957270301549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233036

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

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: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [Handlike]

• 06957270301549: HD-CSXT-001
• 06957270304212: HD-CS-DJ45
• 06957270304205: HD-CS-DJ36
• 06957270304199: HD-CS-DJ22
• 06957270304182: HD-CS-DJ14
• 06957270304175: HD-CSH01
• 06957270304168: HRF-M52
• 06957270304151: HD-CSD01