RHYTHM XIENCE, INC.

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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

Introducer, Catheter (DYB) (6)

Premarket Exempt

Clear

Flextra Steerable Introducer - 00852392007002 Catalog Number :

Device Description : Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Flextra Steerable Introducer - 00852392007019 Catalog Number :

Device Description : Flextra - 65cm - MED Curl Flextra Steerable Introducer 65cm Med Curl 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Guider Catheter Introducer - 00852392007026 Catalog Number :

Device Description : Guider - 50cm - L1 Guider Catheter Introducer 50 L1 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Guider Catheter Introducer - 00852392007033 Catalog Number :

Device Description : Guider - 50cm - L2 Guider Catheter Introducer 50 L2 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Guider Catheter Introducer - 00852392007040 Catalog Number :

Device Description : Guider - 65cm - L1 Guider Catheter Introducer 65 L1 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Guider Catheter Introducer - 00852392007057 Catalog Number :

Device Description : Guider - 65cm - L2 Guider Catheter Introducer 65 L2 8.5F

Device Class : 2

Duns Number: 035028367

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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