AquaBeam Robotic System AB2000-D

GUDID 00850055427020

PROCEPT BIOROBOTICS CORPORATION

Water jet knife system

• Primary Device ID: 00850055427020
• NIH Device Record Key: 4ba4f14f-061a-4f3b-8c65-abba84ceed53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBeam Robotic System
• Version Model Number: AB2000
• Catalog Number: AB2000-D
• 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: false
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
GS1	00850055427020 [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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [AquaBeam Robotic System]

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