AquaBeam Robotic System

Basic Information

• Brand Name: AquaBeam Robotic System
• Primary DI: 00850055427020
• Version / Model: AB2000
• Catalog Number: AB2000-D, AB2000-E
• Company Name: PROCEPT BIOROBOTICS CORPORATION
• Labeler DUNS: 016646472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 3
• Public Version Date: 2023-12-28
• Public Version Status: Update
• Public Device Record Key: 4ba4f14f-061a-4f3b-8c65-abba84ceed53

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZP	Fluid jet removal system	General, Plastic Surgery	876.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45396	Water jet knife system	An assembly of devices designed to surgically cut/dissect soft body tissues using a stream of high pressure water, leaving hard/elastic structures (e.g., bone, ligaments) intact. It includes a mains electricity (AC-powered) generator to create the hydraulic pressure, tubing, and a handpiece to direct and apply the cutting stream of water; this is typically sterile saline. It may also assist in the irrigation of the surgical site to help improve site visibility. The system is commonly used to remove burned/damaged skin, tumours, and varicose veins; it may be used endoscopically.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850055427020	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN170024	000
K231024	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius