NEUWAVE NWF2HK1N

GUDID 00818913020073

NW Flex System, Hong Kong

NEUWAVE MEDICAL, INC.

Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator Microwave ablation system generator
Primary Device ID00818913020073
NIH Device Record Key844100f4-ebd7-4e1c-ae95-3aef8b73ebb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEUWAVE
Version Model NumberNWF2HK1N
Catalog NumberNWF2HK1N
Company DUNS809758878
Company NameNEUWAVE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com
Phone+1(877)323-9283
Emailinfo@neuwave.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818913020073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [NEUWAVE]

00853719006302NEUWAVE Flex System, US
00853719006982NEUWAVE Arm 2 Dovetail Rail
00853719006975NEUWAVE Arm 1 OR Table Rail
00853719006555NEUWAVE Ablation System, US
00853719006999NEUWAVE Ablation System with Ablation Confirmation, US
00853719006531Surgical Probe Kit
00853719006524Surgical PDM Mount Kit
00853719006517Footswitch Locking USB
00853719006500Footswitch Standard USB
00853719006548Dual Resection Probe Clip
00853719006487CT Bed Rail Mount, Siemens Alt
00853719006470CT Bed Rail Mount, Toshiba
00853719006463CT Bed Rail Mount, Siemens
00853719006456CT Bed Rail Mount, GE/Philips
00853719006449NEUWAVE Surgical Tool
00853719006432NEUWAVE SR Probe 25CM 13ga
00853719006425NEUWAVE PR XT Probe 20CM 15ga
00853719006418NEUWAVE PR Probe 20CM 17ga
00853719006401NEUWAVE PR XT Probe 15CM 15ga
00853719006395NEUWAVE PR Probe 15CM 17ga
00853719006388NEUWAVE LK XT Probe 20CM 15ga
00853719006371NEUWAVE LK Probe 20CM 17ga
00853719006364NEUWAVE LK XT Probe 15CM 15ga
00853719006357NEUWAVE LK Probe 15CM 17ga
00853719006340NEUWAVE LN Probe 20CM 17ga
00853719006333NEUWAVE LN Probe 15CM 17ga
00853719006326NEUWAVE Flex Probe 6
00853719006319NEUWAVE Flex Probe 4
10818913020506NEUWAVE PRS Probe 15CM 15ga
00818913020189NEUWAVE Flex MAS, 220-230VAC
00818913020172NW CERTUS Flex System, China
00818913020158NW Flex System, Singapore
00818913020073NW Flex System, Hong Kong

Trademark Results [NEUWAVE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUWAVE
NEUWAVE
87218388 not registered Live/Pending
NeuWave Medical, Inc.
2016-10-27

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