AquaBeam Handpiece HP2000

GUDID B614HP20001

PROCEPT BIOROBOTICS CORPORATION

Water jet knife system handpiece, single-use Water jet knife system handpiece, single-use Water jet knife system handpiece, single-use Water jet knife system handpiece, single-use Water jet knife system handpiece, single-use

• Primary Device ID: B614HP20001
• NIH Device Record Key: 615abdc0-4382-4ca3-9d23-69786a6ac748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBeam Handpiece
• Version Model Number: HP2000
• Catalog Number: HP2000
• Company DUNS: 016646472
• Company Name: PROCEPT BIOROBOTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B614HP20001 [Previous]
HIBCC	B614HP2000X1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212835

FDA Product Code

• PZP: Fluid jet removal system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [AquaBeam Handpiece]

• B6143103011: HP2000
• B614HP20001: HP2000
• 00850055427006: HP2000
• 00850055427037: HP2000