CUSTOMED INC

Address:CALLE IGUALDAD No. 7,Fajardo,PR,00738,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

Instrument, Biopsy (KNW) (9) Wrap, Sterilization (FRG) (1)

Premarket Exempt

No Yes

Clear

CUSTOMED - M20890009918160 Catalog Number : 9000991816

Device Description : CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR BARD MAGNUM WITH COAXIAL NEEDLE, 18G X 160MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890009918250 Catalog Number : 9000991825

Device Description : CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR BARD MAGNUM WITH COAXIAL NEEDLE, 18G X 250MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890010702 Catalog Number : 9001070

Device Description : STERILIZATION WRAPPER DISPOSABLE 36" X 36"

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 250

CUSTOMED - M20890010918120 Catalog Number : 9001091812

Device Description : CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 120MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890010918160 Catalog Number : 9001091816

Device Description : CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 160MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890010918250 Catalog Number : 9001091825

Device Description : CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 250MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890017018160 Catalog Number : 9001701816

Device Description : CUSTOMED CHIBA BIOPSY FINE ASPIRATION NEEDLE, 18G X 160MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890017018200 Catalog Number : 9001701820

Device Description : CUSTOMED CHIBA BIOPSY FINE ASPIRATION NEEDLE, 18G X 200MM, PINK

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890017020160 Catalog Number : 9001702016

Device Description : CUSTOMED CHIBA BIOPSY FINE ASPIRATION NEEDLE, 20G X 160MM, YELLOW

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CUSTOMED - M20890017020200 Catalog Number : 9001702020

Device Description : CUSTOMED CHIBA BIOPSY FINE ASPIRATION NEEDLE, 20G X 200MM, YELLOW

Device Class :

Duns Number: 627572217

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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