FDA.reportPublic FDA data

Styro-former, Basic SF319A

Primary DI
00850077007170
Brand
Styro-former, Basic SF319A
Company
HUESTIS MACHINE CORPORATION
Model
SF319A
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,
Published
2017-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077007170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077007170008500770071708500770071700850077007170

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy beam block production hot-wireA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001188390
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077007293Huestis Medical Flexi-HolderFH303DP-122025-03-05
00850077007286Huestis Medical CollimatorCM-32211-QMI2021-04-02
00850077007279Huestis Medical CollimatorCM-3201-1022021-03-19
00850077007255Huestis Centralite Patient Positioning LaserCTL-DLL-22142021-02-18
00850077007262Huestis Centralite Patient Positioning LaserCTL-DLG-22142021-02-18
00850077007217Huestis Centralite Patient Positioning LaserDLG22021-02-04
00850077007224Huestis Centralite Patient Positioning LaserDLL22021-02-04
00850077007231Huestis Centralite Patient Positioning LaserDLL42021-02-04
00850077007248Huestis Centralite Patient Positioning LaserDLG42021-02-04
00850077007002Huestis Medical CollimatorCM-11002016-07-01
00850077007019Huestis Medical CollimatorCM-3201-0082016-07-18
00850077007026Huestis Medical CollimatorCM-32012-0082016-07-18
00850077007033Huestis Medical CollimatorCM-10032016-07-18
00850077007040Huestis Medical Flexi-HolderFH410-GE2016-07-18
00850077007057Huestis Medical CollimatorCM-3300B-0022016-07-18
00850077007064Huestis Medical CollimatorCM-32001-COV2016-07-18
00850077007071Huestis Medical Flexi-HolderFH3032017-06-19
00850077007088Huestis Medical Flexi-HolderFH303-12016-11-01
00850077007095Huestis Medical Flexi-HolderFH4102016-11-01
00850077007101Huestis Medical Flexi-HolderFH410-12016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871220IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
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00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
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00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
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00816611026069Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30