AquaBeam Handpiece

Basic Information

• Brand Name: AquaBeam Handpiece
• Primary DI: 00850055427006
• Version / Model: HP2000
• Catalog Number: HP2000-D
• 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: e2f33579-11ca-407e-be11-1c2ce411eca6

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Sterilization Methods: Ethylene Oxide

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
47559	Water jet knife system handpiece, single-use	A sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850055427006	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212835	000
K231024	000

Storage Conditions

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