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

Accelerator, Linear, Medical (IYE) (4) Marker, Radiographic, Implantable (NEU) (4) Agent, Bulking, Injectable For Gastro-Urology Use (LNM) (2) Staple, Implantable (GDW) (1)

Premarket Exempt

No Yes

Clear

BIOMARC ® EX - 00850002461305 Catalog Number : 040165

Device Description : FIDUCIAL MARKER SYSTEM

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Durasphere ® EXP - 00858015005004 Catalog Number : 890-215

Device Description : Injectable Bulking Agent

Device Class : 3

Duns Number: 883094039

Premarket Exempt : No

Product Code : LNM

Prescription Use : Yes

Device Count : 1

Durasphere ® EXP - 00858015005011 Catalog Number : 890-216

Device Description : Injectable Bulking Agent

Device Class : 3

Duns Number: 883094039

Premarket Exempt : No

Product Code : LNM

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005028 Catalog Number : 040137

Device Description : Marker System, PRO

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005035 Catalog Number : 040138

Device Description : Marker System, PRO

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005042 Catalog Number : 040139

Device Description : Fiducial Marker System, PRO

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

BiomarC® - 00858015005059 Catalog Number : 040140

Device Description : Fiducial Marker System, EX

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BiomarC ® - 00858015005066 Catalog Number : 040101

Device Description : Tissue Marker, kV

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : NEU, GDW

Prescription Use : Yes

Device Count : 1

BiomarC ® - 00858015005073 Catalog Number : 040133

Device Description : Fiducial Marker, Gold

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BiomarC ® - 00858015005080 Catalog Number : 040142

Device Description : Fiducial Marker - EX

Device Class : 2

Duns Number: 883094039

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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