AquaBeam Scope SC2000-D

GUDID 00850055427013

PROCEPT BIOROBOTICS CORPORATION

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• Primary Device ID: 00850055427013
• NIH Device Record Key: 57652011-a500-465d-9c43-4d6f3af68c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBeam Scope
• Version Model Number: SC2000
• Catalog Number: SC2000-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: 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: 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	00850055427013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212835

FDA Product Code

• PZP: Fluid jet removal system

Sterilization

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

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[00850055427013]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

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 Scope]

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