Medical Components, Inc.

Address:1499 DELP DRIVE,HARLEYSVILLE,PA,19438,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

Catheter, hemodialysis, implanted (MSD) (4) Accessories, a-v shunt (KNZ) (3) INTRODUCER, CATHETER (DYB) (3)

Premarket Exempt

No Yes

Clear

Duo-Flow®XTP - 00884908000184 Catalog Number :

Device Description : 11.5F X 15CM Duo-Flow® XTP STRAIGHT FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : KNZ

Prescription Use : Yes

Device Count : 1

Duo-Flow®XTP - 00884908000191 Catalog Number :

Device Description : 11.5F X 20CM Duo-Flow®XTP STRAIGHT FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : KNZ

Prescription Use : Yes

Device Count : 1

Duo-Flow®XTP - 00884908000207 Catalog Number :

Device Description : 11.5F X 24CM Duo-Flow®XTP STRAIGHT FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : KNZ

Prescription Use : Yes

Device Count : 1

Bio-Flex®Tesio® Catheters - 00884908000498 Catalog Number :

Device Description : 10F Bio-Flex®Tesio® CATHETERS (RIGHT) (ARTERIAL CUFF - 22CM FROM TIP) (VENOUS CU 10F Bio-Flex®Tesio® CATHETERS (RIGHT) (ARTERIAL CUFF - 22CM FROM TIP) (VENOUS CUFF - 25CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Bio-Flex®Tesio® Catheters - 00884908000504 Catalog Number :

Device Description : 10F Bio-Flex®Tesio® CATHETERS (LEFT) (ARTERIAL CUFF - 27CM FROM TIP) (VENOUS CUF 10F Bio-Flex®Tesio® CATHETERS (LEFT) (ARTERIAL CUFF - 27CM FROM TIP) (VENOUS CUFF - 30CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Tesio® Extension Set - 00884908000511 Catalog Number :

Device Description : Tesio® ARTERIAL EXTENSION SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Tesio® Extension Set - 00884908000528 Catalog Number :

Device Description : Tesio® VENOUS EXTENSION SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER - 00884908000559 Catalog Number :

Device Description : 15F VALVED PEELABLE INTRODUCER

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER - 00884908000566 Catalog Number :

Device Description : 16F VALVED PEELABLE INTRODUCER

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

MICRO STICK SETMICRO STICK SET - 00884908000634 Catalog Number :

Device Description : 0.018" (0.47MM) X 45CM0.018" (0. NITINOL GUIDEWIRENITINOL GUIDEWI W/RADIOPAQUE T 0.018" (0.47MM) X 45CM0.018" (0. NITINOL GUIDEWIRENITINOL GUIDEWI W/RADIOPAQUE TIPW/RADIOPAQUE TIP

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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