None

Basic Information

• Brand Name: None
• Primary DI: 00886874112731
• Version / Model: 480275
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 4
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 3f583be0-ef14-4704-9437-6ada7180ac6a

Device Description

HARMONIC ACE

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAY	System,surgical,computer controlled instrument	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63120	Soft-tissue ultrasonic robotic surgical instrument, single-use	A sterile component of an ultrasonic surgical assembly intended to be connected directly to the arm of a robotic surgical system, and convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is typically in the form of an elongated probe with a proximal housing intended to attach to the robotic arm. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10886874112738	GS1	BOX	6	In Commercial Distribution
Primary	00886874112731	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter