CREGANNA UNLIMITED COMPANY

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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) (10) Catheter, Cholangiography (GBZ) (2)

Premarket Exempt

Clear

Gore TIPS Needle - 05391526210000 Catalog Number : TNDL1656

Device Description : Gore TIPS Needle

Device Class : 1

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB, GBZ

Prescription Use : Yes

Device Count : 1

Gore TIPS® Sheath - 05391526210017 Catalog Number : TSTH1040

Device Description : Gore TIPS® Sheath

Device Class : 1

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB, GBZ

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210031 Catalog Number : M004EPTMC85300

Device Description : Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210048 Catalog Number : M004EPTMCA85400

Device Description : Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210055 Catalog Number : M004USMC85100

Device Description : Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210062 Catalog Number : M004USMCA85200

Device Description : Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210079 Catalog Number : M004JPNMC85500

Device Description : Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Zurpaz™ Steerable Sheath Set - 05391526210086 Catalog Number : M004JPNMCA85600

Device Description : Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Lotus™ Introducer Set - 05391526210109 Catalog Number : LIS-S

Device Description : Lotus™ Introducer Set, Small

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Lotus™ Introducer Set - 05391526210116 Catalog Number : LIS-L

Device Description : Lotus™ Introducer Set, Large

Device Class : 2

Duns Number: 985218606

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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