AccessGUDID - DEVICE: Betters (Suzhou)Medical Co., Ltd. (06975283420071)

GUDID

Device Identifier (DI) Information

Brand Name: Betters (Suzhou)Medical Co., Ltd.
Version or Model: CWZ-1615
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Betters (Suzhou)Medical Co., Ltd.

Primary DI Number: 06975283420071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551474420 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
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 [?]
K232240	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5612171f-b849-4d44-90c1-d5a40385868f
Public Version Date: June 06, 2024
Public Version Number: 1
DI Record Publish Date: May 29, 2024