AccessGUDID - DEVICE: IntelliBlate Ximitry Probe Assembly, 13G x 15cm (00810563022292)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliBlate Ximitry Probe Assembly, 13G x 15cm
Version or Model: IB-XPA-1315
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOCARE, INC.

Primary DI Number: 00810563022292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928955509 *Terms of Use

Device Description: IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1

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):	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?
66978	Microwave ablation system probe, electrically-powered	An 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) and/or thermocouple(s) to help control the temperature of the probe. The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), non-surgically invasive and open surgery procedures to ablate tissues. 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 [?]
K240480	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: 32d76bef-6e1c-4c4c-8ddb-638bf1b55e4b
Public Version Date: August 19, 2024
Public Version Number: 1
DI Record Publish Date: August 09, 2024