AccessGUDID - DEVICE: NEUWAVE (00853719006326)

GUDID

Device Identifier (DI) Information

Brand Name: NEUWAVE
Version or Model: FLEX6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FLEX6
Company Name: NEUWAVE MEDICAL, INC.

Primary DI Number: 00853719006326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809758878 *Terms of Use

Device Description: NEUWAVE Flex Probe 6

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:	Yes
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?
61286	Microwave ablation system probe, non-powered	A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 150 Centimeter
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: dcea22a3-6da2-46be-a2e5-8cd4ae71c470
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: September 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10853719006323	5	00853719006326		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)323-9283
Email: info@neuwave.com

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