AccessGUDID - DEVICE: IntelliBlate Microwave Ablation System Console (00810563022278)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliBlate Microwave Ablation System Console
Version or Model: IB-CON
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOCARE, INC.

Primary DI Number: 00810563022278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928955509 *Terms of Use

Device Description: IntelliBlate microwave ablation system console only for tabletop configuration

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):	No
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?
66977	Microwave ablation system	An assembly of devices intended to generate and administer microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. It consists of an electrically-powered microwave energy generator, a user interface, and controls; a microwave ablation probe (not included) is used for energy application to the target area. 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 [?]
K240480	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26f3a7a2-1f90-47be-8809-a94076c08ea2
Public Version Date: August 19, 2024
Public Version Number: 1
DI Record Publish Date: August 09, 2024