AquaBeam Scope SC2000

GUDID B614SC20000

PROCEPT BIOROBOTICS CORPORATION

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