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, Peripheral, Atherectomy (MCW) (5) Insert, Tubal Occlusion (HHS) (2) Catheter, Continuous Flush (KRA) (1) Catheter, Coronary, Atherectomy (MCX) (1) Wire, Guide, Catheter (DQX) (1)

Premarket Exempt

Clear

DISTAFLEX - 00616258005096 Catalog Number : 111304

Device Description : DISTA FLEX, FG PKG

Device Class : 3

Duns Number: 079415074

Premarket Exempt : No

Product Code : MCX

Prescription Use : Yes

Device Count : 1

POWER PULSE - 00616258005102 Catalog Number : 104834

Device Description : PPS ANCILLARY PACK, FG PKG

Device Class :

Duns Number: 079415074

Premarket Exempt : No

Product Code : KRA

Prescription Use : Yes

Device Count : 1

JETSTREAM - 00616258005119 Catalog Number : 050599

Device Description : JETSTREAM CONSOLE

Device Class : 2

Duns Number: 079415061

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

JETSTREAM SC - 00616258005126 Catalog Number : 112260

Device Description : JETSTREAM SC 1.6MM, FG PKG

Device Class : 2

Duns Number: 079415061

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

JETSTREAM SC - 00616258005133 Catalog Number : 112262

Device Description : JETSTREAM SC 1.85MM, FG PKG

Device Class : 2

Duns Number: 079415061

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

JETSTREAM XC - 00616258005140 Catalog Number : 112264

Device Description : JETSTREAM XC 2.1 MM, FG PKG

Device Class : 2

Duns Number: 079415061

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

JETSTREAM XC - 00616258005157 Catalog Number : 112266

Device Description : JETSTREAM XC 2.4MM, FG PKG

Device Class : 2

Duns Number: 079415061

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

JETWIRE - 00616258005164 Catalog Number : 011525

Device Description : JETSTREAM GUIDEWIRE

Device Class :

Duns Number: 079415061

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Essure - 00888853030517 Catalog Number :

Device Description : Essure is a permanent Birth Control System. One Essure Replacement Kit containi Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.

Device Class : 3

Duns Number: 797856572

Premarket Exempt : No

Product Code : HHS

Prescription Use : No

Device Count : 1

Essure - 10888853003051 Catalog Number :

Device Description : Essure is a permanent Birth Control System. One Essure pouched disposable deliv Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved introducer. Two Pouched Delivery Systems are contained in the Essure Kit and are not sold separately.

Device Class : 3

Duns Number: 797856572

Premarket Exempt : No

Product Code : HHS

Prescription Use : No

Device Count : 1

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