HUESTIS MACHINE CORPORATION

Address:68 BUTTONWOOD ST.,Bristol,RI,02809,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Collimator, Manual, Radiographic (IZX) (5) Cassette, Radiographic Film (IXA) (3) Accelerator, Linear, Medical (IYE) (1) Shield, Protective, Personnel (KPY) (1)

Premarket Exempt

No Yes

Clear

Huestis Medical Flexi-Holder - 00850077007101 Catalog Number :

Device Description : Flexi-Holder W/Artic 36" Arm, Huestis Part # FH410-1

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Husetis Medical Flexi-Holder - 00850077007118 Catalog Number :

Device Description : Flexi-Holder GE W/Artic 26" Arm, Huestis Part# FH410-GE

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Huestis Medical Flexi-Holder - 00850077007125 Catalog Number :

Device Description : Flexi-Holder GE W/Artic 36" Arm, Huestis Part # FH410-GE-1

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007132 Catalog Number :

Device Description : 150PBL/SC Collimator, ( Huestis Part # CM-3201-201 )

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007149 Catalog Number :

Device Description : 150PBL/SC Thin Mirror Collimator, ( Huestis Part # CM-3201-201 )

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007156 Catalog Number :

Device Description : 150M/XL AUX FL CABLE COLLIMATOR ( HUESTIS PART # CM-1020A-201)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Compu-Cutter 111 - 00850077007163 Catalog Number :

Device Description : Compu-cutter shielding bolck cutters cut foam block molds so that extremely prec Compu-cutter shielding bolck cutters cut foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment.

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Styro-former, Basic SF319A - 00850077007170 Catalog Number :

Device Description : Styro-former shielding block cutter cuts foam block molds so that extremely prec 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 Class : 1

Duns Number: 001188390

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

Huestis Medical Collilmator - 00850077007187 Catalog Number :

Device Description : X-Ray Collimator, Automatic, Huestis Part # CM-42054-102 (PBL-RRE/RXL/SF)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007194 Catalog Number :

Device Description : X-Ray Collimator, Huestis Part # CM-42015-001 PBL-RE/SC/IS/MSF QMI/GENERIC

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

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