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) (6) Cassette, Radiographic Film (IXA) (4)

Premarket Exempt

No Yes

Clear

Huestis Medical Collimator - 00850077007002 Catalog Number :

Device Description : X-Ray Collimator, Manual

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007019 Catalog Number :

Device Description : Collimator FRU for Definium 5000, (Huestis Part # CM-3201-008), (GEHC Part # 521 Collimator FRU for Definium 5000, (Huestis Part # CM-3201-008), (GEHC Part # 5212898), (GE # 6693-50GE), (GE Catalog # B1100SL)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007026 Catalog Number :

Device Description : 6693-50FGE Automatic Collimator customized for GE with spectral filters, (Huesti 6693-50FGE Automatic Collimator customized for GE with spectral filters, (Huestis Part# CM-32012-008), (GEHC Part # 5220504)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007033 Catalog Number :

Device Description : Collimator, Urology SCD, (Huestis Part # CM-1003), (GEHC part # 00-901620-01)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Flexi-Holder - 00850077007040 Catalog Number :

Device Description : Flexi-Holder W/Artic 26 Arm, (Huestis Part # FH410-GE), (GEHC Part # E6314J)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007057 Catalog Number :

Device Description : 150PBL-I Collimator, Iris Selectable, (Huestis Part# CM-3300B-002), (Liebel Part# 740920)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Collimator - 00850077007064 Catalog Number :

Device Description : COVIDIEN PBL/HW/IS OEM Features, (Huestis Part# CM-32001-COV), (Liebel Part# 740925)

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IZX

Prescription Use : No

Device Count : 1

Huestis Medical Flexi-Holder - 00850077007071 Catalog Number :

Device Description : Flexi-Holder 26" Short Arm, Huestis Part # FH303

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Huestis Medical Flexi-Holder - 00850077007088 Catalog Number :

Device Description : Flexi-Holder 36" Long Arm, Huestis Part # FH303-1

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Huestis Medical Flexi-Holder - 00850077007095 Catalog Number :

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

Device Class : 2

Duns Number: 001188390

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

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