AccessGUDID - DEVICE: NEUWAVE (00818913020073)

GUDID

Device Identifier (DI) Information

Brand Name: NEUWAVE
Version or Model: NWF2HK1N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NWF2HK1N
Company Name: NEUWAVE MEDICAL, INC.

Primary DI Number: 00818913020073
Issuing Agency: GS1
Commercial Distribution End Date: April 08, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 809758878 *Terms of Use

Device Description: NW Flex System, Hong Kong

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61287	Microwave ablation system generator	A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163118	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -22 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 844100f4-ebd7-4e1c-ae95-3aef8b73ebb0
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: March 31, 2021