AquaBeam Scope SC2000

GUDID B614SC20000

PROCEPT BIOROBOTICS CORPORATION

Rigid endoscope telescope 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 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 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 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 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 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 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 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 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 Water jet knife system handpiece, single-use Water jet knife system handpiece, single-use Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope

• Primary Device ID: B614SC20000
• NIH Device Record Key: 52f2de03-0c7a-4b19-8151-e5f8ef368978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBeam Scope
• Version Model Number: SC2000
• Catalog Number: SC2000
• 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: true
• 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-biorob
• 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
• 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
• 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
HIBCC	B6142105011 [Previous]
HIBCC	B614SC20000 [Direct Marking]
HIBCC	B614SC20001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170024

FDA Product Code

• PZP: Fluid jet removal system

Sterilization

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

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

[B614SC20000]

Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [AquaBeam Scope]

• B6142105011: 210501
• B614SC20000: SC2000
• 00850055427013: SC2000