Solero
GUDID H787700106003US0
Microwave Tissue Ablation Applicator
NAVILYST MEDICAL, INC.
Microwave hyperthermia system applicator, intracorporeal| Primary Device ID | H787700106003US0 |
| NIH Device Record Key | 9952a626-1105-4745-afe2-6701cc49a69c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solero |
| Version Model Number | 700106003-US |
| Company DUNS | 809699023 |
| Company Name | NAVILYST MEDICAL, 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 | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Device Dimensions
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
| Length | 29 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684017862 [Secondary] |
| HIBCC | H787700106003US0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162449
FDA Product Code
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-10 |
On-Brand Devices [Solero]
| H787700106003US0 | Microwave Tissue Ablation Applicator |
| H787700106002US0 | Microwave Tissue Ablation Applicator |
| H787700106001US0 | Microwave Tissue Ablation Applicator |
| H78712740000US0 | MTA System |
Trademark Results [Solero]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLERO 97245022 not registered Live/Pending |
Solero Technologies, LLC 2022-01-29 |
 SOLERO 90132284 not registered Live/Pending |
S.S. Steiner, Inc. 2020-08-24 |
 SOLERO 88413583 5908073 Live/Registered |
P Music Group, Inc. 2019-05-02 |
 SOLERO 88283722 not registered Live/Pending |
McKesson Europe AG 2019-01-31 |
 SOLERO 87345195 5493190 Live/Registered |
Conopco, Inc. 2017-02-22 |
 SOLERO 87315419 not registered Dead/Abandoned |
P Music Group, Inc. 2017-01-26 |
 SOLERO 87315410 not registered Live/Pending |
P Music Group, Inc. 2017-01-26 |
 SOLERO 87315408 not registered Dead/Abandoned |
P Music Group, Inc. 2017-01-26 |
 SOLERO 87100756 5722693 Live/Registered |
AngioDynamics, Inc. 2016-07-12 |
 SOLERO 86301004 not registered Dead/Abandoned |
AngioDynamics, Inc. 2014-06-05 |
 SOLERO 78933018 3552121 Live/Registered |
Nachman International USA Inc. 2006-07-19 |
 SOLERO 78028827 2593015 Dead/Cancelled |
Milliken & Company 2000-10-03 |
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