CONCURE ONCOLOGY, INC.

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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

System, Applicator, Radionuclide, Manual (IWJ) (6) Shield, Protective, Personnel (KPY) (1) System, Applicator, Radionuclide, Remote-Controlled (JAQ) (1)

Premarket Exempt

No Yes

Clear

BMT Template Grid Armature & Table Clamp - 00860003072714 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Armrest Armature & Table Clamp - 00860003072721 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Template Grid, Vertical Lock, Large - 00860003072738 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Cleaning Brush Set, Vertical Lock - 00860003072745 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Fiducial Needle, Sharp - 00860003072752 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Fiducial Needle, Round - 00860003072769 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

BMT Breast Shield - 00860003072776 Catalog Number :

Device Class : 1

Duns Number: 056124661

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : Yes

Device Count : 1

Obturator and Caps - 00860005821204 Catalog Number :

Device Class : 2

Duns Number: 056124661

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

BMT Localizer Needle Kit - 00860005821211 Catalog Number :

Device Class :

Duns Number: 056124661

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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