Merit Medical

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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) (7) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (3)

Premarket Exempt

No Yes

Clear

SafeSheath CSG - 00884450162033 Catalog Number : FCL-083-00

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SafeSheath CSG - 00884450162040 Catalog Number : FCL-083-01

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SafeSheath CSG - 00884450162057 Catalog Number : FCL-083-02

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SafeSheath CSG - 00884450162064 Catalog Number : FCL-083-03

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SafeSheath CSG - 00884450162101 Catalog Number : FCL-090-00

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

H. Lee SafeSheath® Sealing Adapter - 00884450162118 Catalog Number : SS-SA-09

Device Class : 2

Duns Number: 065673912

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : No

Device Count : 1

H. Lee SafeSheath® Sealing Adapter - 00884450162132 Catalog Number : SSSA-09

Device Class : 2

Duns Number: 065673912

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : No

Device Count : 1

H. Lee SafeSheath® Sealing Adapter - 00884450162149 Catalog Number : SSSA-EW-09

Device Class : 2

Duns Number: 065673912

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : No

Device Count : 1

SafeSheath® Worley - 00884450162286 Catalog Number : LVI/75-5-62-07-RE

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SafeSheath® Worley - 00884450162293 Catalog Number : FCL-137-01

Device Class : 2

Duns Number: 065673912

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

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