AccessGUDID - DEVICE: Styro-former, Basic SF319A (00850077007170)

GUDID

Device Identifier (DI) Information

Brand Name: Styro-former, Basic SF319A
Version or Model: SF319A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HUESTIS MACHINE CORPORATION

Primary DI Number: 00850077007170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001188390 *Terms of Use

Device Description: Styro-former shielding block cutter cuts foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment,

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?
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
KPY	Shield, Protective, Personnel

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 18ac3cc0-a757-40d5-bdc6-aed9d2386b21
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 20, 2017