CORTEX MANUFACTURING INC.

Address:421 South Davies Rd.,Lake Stevens,WA,98258,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

Marker, Radiographic, Implantable (NEU) (7) Accelerator, Linear, Medical (IYE) (3)

Premarket Exempt

Clear

FusionCoil™ - 00853730006206 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006213 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006220 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006237 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006244 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006251 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

FusionCoil™ - 00853730006268 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

Needle - 00853730006275 Catalog Number :

Device Description : Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

SureLock™ - 00853730006282 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Gold Markers - 00853730006299 Catalog Number :

Device Description : Implanted Marker in Needle

Device Class : 2

Duns Number: 832596816

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

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