Bayer Healthcare LLC

Bayer Healthcare LLC

Address:36 Columbia Rd,Morristown,NJ,07960,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, Embolectomy (DXE) (9) Catheter, Continuous Flush (KRA) (2) Catheter, Coronary, Atherectomy (MCX) (1)

Premarket Exempt

No

Clear

AVX - 00616258003832 Catalog Number : 105039

Device Description : AVX CUS CATHETER, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

XVG - 00616258003849 Catalog Number : 105042

Device Description : XVG CUS CATHETER, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

SPIROFLEX VG - 00616258003856 Catalog Number : 106608

Device Description : SPIROFLEX VG CUS CATH FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

SPIROFLEX - 00616258003887 Catalog Number : 106553

Device Description : SPIROFLEX CUS CATH, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

XMI - 00616258003894 Catalog Number : 105041

Device Description : XMI CUS CATHETER, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

ANGIOJET - 00616258003900 Catalog Number : 105650

Device Description : ULTRA SYSTEM CONSOLE, FG

Device Class : 3

Duns Number: 079415074

Premarket Exempt : No

Product Code : MCX

Prescription Use : Yes

Device Count : 1

SOLENT PROXI - 00616258003917 Catalog Number : 109676

Device Description : SOLENT PROXI CATH, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : KRA, DXE

Prescription Use : Yes

Device Count : 1

SOLENT OMNI - 00616258003924 Catalog Number : 109681

Device Description : SOLENT OMNI CATHETER, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : KRA, DXE

Prescription Use : Yes

Device Count : 1

FETCH 2 - 00616258003955 Catalog Number : 109400

Device Description : F2 CATHETER FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

SOLENT DISTA - 00616258005089 Catalog Number : 111303

Device Description : SOLENT DISTA, FG PKG

Device Class : 2

Duns Number: 079415074

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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