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

Platform, Force-Measuring (KHX) (3) Screen, Leaded, Operator Radiation Protector (EAK) (3) Probe, Uptake, Nuclear (IZD) (2) Table, Radiographic, Tilting (IXR) (1) Table, Radiologic (KXJ) (1)

Premarket Exempt

No Yes

Clear

ATOMLAB - 00718175000014 Catalog Number : 187-600

Device Description : Thyroid Uptake System, AtomLab 960, 120 VAC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : No

Device Count : 1

ATOMLAB - 00718175000021 Catalog Number : 187-601

Device Description : Thyroid Uptake System, AtomLab 960, 230 VAC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : No

Device Count : 1

BALANCE SD - 00718175000038 Catalog Number : 950-440

Device Description : Balance System SD, 115 VAC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

BALANCE SD - 00718175000045 Catalog Number : 950-441

Device Description : Balance System SD, 230 VAC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

BALANCE SD - 00718175000052 Catalog Number : 950-444

Device Description : Balance System SD, 100 VAC

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

CLEAR LEAD BARRIER - 00718175000069 Catalog Number : 042-585

Device Description : BARRIER, CLEAR-LEAD, 23"Hx48"W, 1.0mmPb

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : EAK

Prescription Use : No

Device Count : 1

CLEAR LEAD BARRIER - 00718175000076 Catalog Number : 042-580

Device Description : BARRIER, CLEAR-LEAD, 24"Hx30"W, 0.5mm Pb

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : EAK

Prescription Use : No

Device Count : 1

CLEAR LEAD BARRIER - 00718175000083 Catalog Number : 042-582

Device Description : BARRIER, CLEAR-LEAD, 54.5"Hx30"W,0.5mmPb

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : EAK

Prescription Use : No

Device Count : 1

Surgical C Arm Table - 00718175000090 Catalog Number : 056-025

Device Description : Table, Surgical C-Arm, Fixed Height

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : No

Device Count : 1

Urology C Arm Table - 00718175000106 Catalog Number : 058-800

Device Description : Table, Urology C-Arm-800,115VAC

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : No

Device Count : 1

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