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

Marker, Radiographic, Implantable (NEU) (8) Accelerator, Linear, Medical (IYE) (2) Staple, Implantable (GDW) (1)

Premarket Exempt

No Yes

Clear

BiomarC® - 00858015005097 Catalog Number : 040400

Device Description : Preloaded Carbon Tissue Marker, Needle Tip Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005103 Catalog Number : 040401

Device Description : Preloaded Carbon Tissue Marker, Needle Tip Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005110 Catalog Number : 040402

Device Description : Preloaded Carbon Tissue Marker, Distal Delivery

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : GDW, NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005127 Catalog Number : 040109

Device Description : Carbon Tissue Marker System, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005134 Catalog Number : 040115

Device Description : Fiducial Marker System, Gold

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005141 Catalog Number : 040119

Device Description : Carbon Tissue Marker System, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005158 Catalog Number : 040120

Device Description : Fiducial Marker System, Gold

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005165 Catalog Number : 040121

Device Description : Carbon Tissue Marker System, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005172 Catalog Number : 040122

Device Description : Carbon Tissue Marker System with Enhanced Visibility, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005189 Catalog Number : 040123

Device Description : Carbon Tissue Marker System with Enhanced Visibility, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

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