AquaBeam Scope 210501

GUDID B6142105011

PROCEPT BIOROBOTICS CORPORATION

Rigid endoscope telescope Rigid endoscope telescope

• Primary Device ID: B6142105011
• NIH Device Record Key: 63d23ae5-f5c2-4c65-9329-795583d07649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBeam Scope
• Version Model Number: 210501
• Catalog Number: 210501
• Company DUNS: 016646472
• Company Name: PROCEPT BIOROBOTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6142105011 [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

[B6142105011]

Hydrogen Peroxide;Ethylene Oxide

[B6142105011]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-11

On-Brand Devices [AquaBeam Scope]

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