NanoKnife

GUDID H78720300301US0

NanoKnife Generator 3.0

ANGIODYNAMICS, INC.

Irreversible electroporation system

• Primary Device ID: H78720300301US0
• NIH Device Record Key: 3bd57ff6-a658-4ede-bbc2-c5f5baaa56b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoKnife
• Version Model Number: 20300301US
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, INC.
• 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: false
• 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684013727 [Secondary]
HIBCC	H78720300301US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183385

FDA Product Code

• OAB: Low energy direct current thermal ablation 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: 2019-07-09
• Device Publish Date: 2019-07-01

On-Brand Devices [NanoKnife]

• H787204003015: Single Electrode Probe Spacer
• H787204001080: NanoKnife Disposable Single Electrode Probe
• H787204001070: NanoKnife Disposable Single Electrode Probe
• H787204001065: NanoKnife Disposable Single Electrode Probe
• H787204001060: NanoKnife Disposable Single Electrode Probe
• H787204001055: NanoKnife Single Electrode Activation Probe
• H787204001050: NanoKnife Single Electrode Activation Probe
• H787204001045: NanoKnife Disposable Single Electrode Probe
• H787204001040: NanoKnife Disposable Single Electrode Probe
• H787204001035: NanoKnife Single Electrode Activation Probe
• H787204001030: NanoKnife Single Electrode Activation Probe
• H787204001025: NanoKnife Disposable Single Electrode Probe
• H787204001015: NanoKnife Disposable Single Electrode Probe
• H78720300101US0: NanoKnife Generator
• H787203001010: NanoKnife Generator
• H787204001100: NanoKnife Disposable Single Electrode Probe
• H787204001090: NanoKnife Disposable Single Electrode Probe
• H78720300301US0: NanoKnife Generator 3.0
• 15051684029643: NanoKnife Disposable Single Electrode 5 Probe Pack - Activation