AQUABEAM Robotic System AB2000

GUDID B614AB2000

PROCEPT BIOROBOTICS CORPORATION

Water jet knife system

• Primary Device ID: B614AB2000
• NIH Device Record Key: a840e395-3d07-438d-8fef-05ec2682efa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUABEAM Robotic System
• Version Model Number: AB2000
• Catalog Number: AB2000
• 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: (650)232-7222
• Email: customerservice@procept-biorob
• Phone: (650)232-7222
• Email: customerservice@procept-biorob

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B614AB2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170024

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: 2019-03-01
• Device Publish Date: 2019-01-29

On-Brand Devices [AQUABEAM Robotic System]

• B614AB2000: AB2000
• B6142101011: AB2000
• B614AB2000C1: AB2000C
• 00850055427020: AB2000