AccessGUDID - DEVICE: NEUWAVE (10818913020698)

GUDID

Device Identifier (DI) Information

Brand Name: NEUWAVE
Version or Model: PRS35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRS35
Company Name: NEUWAVE MEDICAL, INC.

Primary DI Number: 10818913020698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809758878 *Terms of Use

Device Description: NW SURGICAL PR PROBE 35CM 11GA

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 [?]
K231738	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1358d5f6-c1c6-4a27-b807-02d6fa5c5ca9
Public Version Date: June 24, 2024
Public Version Number: 1
DI Record Publish Date: June 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20818913020695	5	10818913020698		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)384-4266
Email: customersupport@eesus.jnj.com

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