Handlike

Basic Information

• Brand Name: Handlike
• Primary DI: 06957270304151
• Version / Model: HD-CSD01
• Company Name: Hunan Handlike Minimally Invasive Surgery Co., Ltd.
• Labeler DUNS: 544338343
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-16
• Public Version: 1
• Public Version Date: 2024-07-24
• Public Version Status: New
• Public Device Record Key: 87f9f193-0b8d-451c-abe3-97bc66221b99

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
57825	Electrosurgical/ultrasonic surgical system generator	A mains electricity-powered (AC-powered) device designed to provide high frequency electrical current to power connected electrosurgical diathermy instruments (create heat within tissues) and ultrasonic surgical instruments (rapidly vibrate tissues), enabling a combination of methods to cut and/or coagulate tissues during open or laparoscopic surgery; the instruments are not included. The device may be used for various types of surgery (e.g., general, gynaecological, plastic); it is typically regulated by the operator with a hand- or foot-switch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06957270304151	GS1

Premarket Submissions

Submission Number	Supplement Number
K233036	000