NanoKnife

GUDID H787204001045

NanoKnife Disposable Single Electrode Probe

ANGIODYNAMICS, INC.

Irreversible electroporation system

• Primary Device ID: H787204001045
• NIH Device Record Key: 54bf518b-d785-42a6-a7ba-3f8d2778b510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoKnife
• Version Model Number: 20400104
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787204001045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150089

FDA Product Code

• OAB: Low energy direct current thermal ablation system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-22

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