BIODEX MEDICAL SYSTEMS, INC.

Address:49 Natcon Drive,Shirley,NY,11967,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

Table, Radiographic, Tilting (IXR) (6) Shield, Protective, Personnel (KPY) (2) Platform, Force-Measuring (KHX) (1) Probe, Uptake, Nuclear (IZD) (1)

Premarket Exempt

No Yes

Clear

SHIELDED WASTE CONTAINER - 00718175000113 Catalog Number : 039-110

Device Description : Waste Container, Shielded, .25" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

BIOSWAY - 00718175000120 Catalog Number : 950-460

Device Description : BIOSWAY PORTABLE BAL SYS w/CASE

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

ATOMLAB - 00718175000137 Catalog Number : 187-602

Device Description : Thyroid Uptake System, Well Counter

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : No

Device Count : 1

BENCH TOP SHIELD - 00718175000144 Catalog Number : 042-710

Device Description : SHIELD, BENCH TOP, GAMMA, ACRYLIC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

Urology C Arm Table - 00718175000151 Catalog Number : 058-805

Device Description : Table, Urology C-Arm-800, 230 VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

3D Imaging C-Arm Table - 00718175000205 Catalog Number : 058-820

Device Description : Table, 3-D Imaging C-Arm , 115 VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

3D Imaging C Arm Table - 00718175000250 Catalog Number : 058-825

Device Description : Table, 3D Imaging, C-Arm, 230 VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

Surgical C Arm Table - 00718175000304 Catalog Number : 058-870

Device Description : Table, Pain Management C-Arm, 115VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

Surgical C Arm Table - 00718175000359 Catalog Number : 058-875

Device Description : Table, Pain Management C-Arm, 230VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

Surgical C Arm Table - 00718175000403 Catalog Number : 058-840

Device Description : Table, Surgical C-arm, Contour 115VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

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