AccessGUDID - DEVICE: BSD-500 Hyperthermia System (00851551005194)

GUDID

Device Identifier (DI) Information

Brand Name: BSD-500 Hyperthermia System
Version or Model: BSD-500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BSD MEDICAL CORPORATION

Primary DI Number: 00851551005194
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 089326938 *Terms of Use

Device Description: Local Hyperthermia System (U.S.A.)

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?
40783	Microwave hyperthermia system	A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOC	System, rf/microwave hyperthermia, cancer treatment

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5627813-2e19-47ca-8157-1436d069e746
Public Version Date: May 29, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2014