Carbon Medical Technologies, Inc.

Address:1290 HAMMOND RD STE 2,Saint Paul,MN,55110,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

Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (6) Marker, Radiographic, Implantable (NEU) (4) Staple, Implantable (GDW) (1)

Premarket Exempt

No Yes

Clear

BiomarC® - 00858015005592 Catalog Number : 040240

Device Description : Preloaded Tribell Carbon Tissue Marker - Sideport Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : GDW, NEU

Prescription Use : Yes

Device Count : 1

Durasphere ® - 00858015005608 Catalog Number : 890-204

Device Description : Injection Needle, Spinal Tip

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Durasphere ® - 00858015005615 Catalog Number : 890-205

Device Description : Injection Needle, Spinal Tip

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Durasphere ® - 00858015005622 Catalog Number : 890-209

Device Description : Injection Needle, Pencil Point

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Durasphere ® - 00858015005639 Catalog Number : 890-217

Device Description : Injection Needle, Pencil Point

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

BiomarC ® - 00858015005646 Catalog Number : 040143

Device Description : Coaxial Needle

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU, FBK

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005653 Catalog Number : 040321

Device Description : Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005660 Catalog Number : 040316

Device Description : Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

Endoscopic Injection Needle - 00858015005943 Catalog Number : 101087

Device Description : Endoscopic Injection Needle

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Injection Procedure Kit - 00858015005950 Catalog Number : 101088

Device Description : Injection Procedure Kit including Three-Way Stopcock, Fluid Dispensing Connector Injection Procedure Kit including Three-Way Stopcock, Fluid Dispensing Connector and Auxiliary Reservoir Syringe

Device Class :

Duns Number: 883094039

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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