NEUWAVE NWF1US1N
GUDID 00853719006302
NEUWAVE Flex System, US
NEUWAVE MEDICAL, INC.
Microwave ablation system generator| Primary Device ID | 00853719006302 |
| NIH Device Record Key | d04d9dda-f2af-46b6-af18-0b2db7be493f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEUWAVE |
| Version Model Number | NWF1US1N |
| Catalog Number | NWF1US1N |
| Company DUNS | 809758878 |
| Company Name | NEUWAVE 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818913020196 [Primary] |
| GS1 | 00853719006302 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163118
FDA Product Code
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-22 |
On-Brand Devices [NEUWAVE]
| 00853719006302 | NEUWAVE Flex System, US |
| 00853719006982 | NEUWAVE Arm 2 Dovetail Rail |
| 00853719006975 | NEUWAVE Arm 1 OR Table Rail |
| 00853719006555 | NEUWAVE Ablation System, US |
| 00853719006999 | NEUWAVE Ablation System with Ablation Confirmation, US |
| 00853719006531 | Surgical Probe Kit |
| 00853719006524 | Surgical PDM Mount Kit |
| 00853719006517 | Footswitch Locking USB |
| 00853719006500 | Footswitch Standard USB |
| 00853719006548 | Dual Resection Probe Clip |
| 00853719006487 | CT Bed Rail Mount, Siemens Alt |
| 00853719006470 | CT Bed Rail Mount, Toshiba |
| 00853719006463 | CT Bed Rail Mount, Siemens |
| 00853719006456 | CT Bed Rail Mount, GE/Philips |
| 00853719006449 | NEUWAVE Surgical Tool |
| 00853719006432 | NEUWAVE SR Probe 25CM 13ga |
| 00853719006425 | NEUWAVE PR XT Probe 20CM 15ga |
| 00853719006418 | NEUWAVE PR Probe 20CM 17ga |
| 00853719006401 | NEUWAVE PR XT Probe 15CM 15ga |
| 00853719006395 | NEUWAVE PR Probe 15CM 17ga |
| 00853719006388 | NEUWAVE LK XT Probe 20CM 15ga |
| 00853719006371 | NEUWAVE LK Probe 20CM 17ga |
| 00853719006364 | NEUWAVE LK XT Probe 15CM 15ga |
| 00853719006357 | NEUWAVE LK Probe 15CM 17ga |
| 00853719006340 | NEUWAVE LN Probe 20CM 17ga |
| 00853719006333 | NEUWAVE LN Probe 15CM 17ga |
| 00853719006326 | NEUWAVE Flex Probe 6 |
| 00853719006319 | NEUWAVE Flex Probe 4 |
| 10818913020506 | NEUWAVE PRS Probe 15CM 15ga |
| 00818913020189 | NEUWAVE Flex MAS, 220-230VAC |
| 00818913020172 | NW CERTUS Flex System, China |
| 00818913020158 | NW Flex System, Singapore |
| 00818913020073 | NW Flex System, Hong Kong |
| 00853719006753 | NW Ablation System, US |
| 00818913020523 | Surgical Clip, Dual, 15ga or 17ga Probe, 5 Pack |
| 00818913020257 | Upgrade to Certus 140-2.45GHz Ablation Confirmation |
| 00818913020196 | NW Flex System, US |
| 00818913020677 | CT Bed Rail Mount, Flat |
| 20818913020695 | NW SURGICAL PR PROBE 35CM 11GA |
Trademark Results [NEUWAVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUWAVE 98471335 not registered Live/Pending |
Neubau Energy Inc. 2024-03-27 |
 NEUWAVE 97048285 not registered Live/Pending |
Kuo, Youti 2021-09-27 |
 NEUWAVE 87218388 not registered Live/Pending |
NeuWave Medical, Inc. 2016-10-27 |
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