AccessGUDID - DEVICE: Electron Beam Shaping Full System, Siemens 95 cm, Full System (B365524850)

GUDID

Device Identifier (DI) Information

Brand Name: Electron Beam Shaping Full System, Siemens 95 cm, Full System
Version or Model: 52-485
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aktina Corp.

Primary DI Number: B365524850
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787178920 *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:	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?
37215	Radiation therapy beam block production plate	A dedicated device, a dish, used for the manual production of beam blocks which serve to configure a radiation field. This device is used in the production of radiotherapy blocks to cool down the melted metal, e.g., Rose's metal [consisting of lead (Pb), tin (Sn) and bismuth] when this has been poured into the moulds. It may also have the function of vibrating the metal during the cooling process to ensure equal distribution of the metal throughout the mould.	Active	false
37079	Radiation therapy beam block production hot-wire	A mains electricity (AC-powered) device designed with a thin electrically-heated wire (hot-wire) that is used in the manual production of radiation therapy beam blocks (custom-made radiation collimators) which are used to configure a patient specific radiation field. The hot-wire is used to cut out the required patterns (the moulds) in a special Styrofoam material, e.g., Styrodur that will become templates used in the casting of a beam block(s). These moulds are configured from precise modelling data of the area to be treated for each individual patient thereby enabling production of exact beam blocks that control the treatment area during the radiotherapy treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXI	Block, Beam-Shaping, Radiation Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973953	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: 5b67828b-2460-48d0-9ca9-73da0a34a38f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016