NanoKnife
GUDID H787204001100
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system Irreversible electroporation system| Primary Device ID | H787204001100 |
| NIH Device Record Key | 0e0f871b-852b-4b6d-8f01-cea9bbb1d38f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoKnife |
| Version Model Number | 20400110 |
| Company DUNS | 079105071 |
| Company Name | ANGIODYNAMICS, INC. |
| 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 | 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 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Device Dimensions
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 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 |
| 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 |
|---|---|
| GS1 | 15051684017947 [Secondary] |
| HIBCC | H787204001100 [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 | true |
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 |
Trademark Results [NanoKnife]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANOKNIFE 87238899 not registered Live/Pending |
Angiodynamics, Inc. 2016-11-16 |
 NANOKNIFE 85130851 3954994 Live/Registered |
AngioDynamics, Inc. 2010-09-16 |
 NANOKNIFE 77764140 3798592 Live/Registered |
AngioDynamics, Inc. 2009-06-19 |
 NANOKNIFE 77513579 3641013 Dead/Cancelled |
AngioDynamics, Inc. 2008-07-02 |
 NANOKNIFE 77498941 3620734 Live/Registered |
AngioDynamics, Inc. 2008-06-13 |
 NANOKNIFE 77498876 3640982 Live/Registered |
AngioDynamics, Inc. 2008-06-13 |
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