NanoKnife
GUDID H787204001080
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
Irreversible electroporation system| Primary Device ID | H787204001080 |
| NIH Device Record Key | 0bbc9e3b-3330-41ae-8bf1-d9aa3786dd06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoKnife |
| Version Model Number | 20400108 |
| 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 | |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684017923 [Secondary] |
| HIBCC | H787204001080 [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 | 5 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-21 |
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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