AccessGUDID - DEVICE: Sonablate (00868108000229)

GUDID

Device Identifier (DI) Information

Brand Name: Sonablate
Version or Model: 202-17000-0012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FOCUS SURGERY INC

Primary DI Number: 00868108000229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101084143 *Terms of Use

Device Description: Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.

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:	No
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?
40781	Ultrasonic hyperthermia system	An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

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: 028284e2-f7fc-49e7-8375-857cec7c94e6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 24, 2017