Harmonic

Basic Information

• Brand Name: Harmonic
• Primary DI: 20705036002199
• Version / Model: HST02
• Catalog Number: HST02
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 3
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 33d83744-fd49-4b19-b51d-b62b1d5bef88

Device Description

Harmonic Test Tip

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58017	Ultrasonic surgical system handpiece/generator tester	A non-sterile metal [e.g., titanium (Ti)] rod designed to test the ability of an ultrasonic surgical handpiece/generator combination to achieve frequency resonance lock as a means to ascertain that the handpiece and generator function properly together. It is inserted into the handpiece as a substitute for the ultrasonic surgical handpiece tip during testing. It is intended to be used by a healthcare provider in a clinical setting. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10705036002192	GS1
Package	30705036002196	GS1	CASE	25	In Commercial Distribution
Primary	20705036002199	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -35 – 54 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity