CATHERA, 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

Catheter, Continuous Flush (KRA) (10) Catheter, Percutaneous (DQY) (10)

Premarket Exempt

Clear

Phenom™ Catheter - 00814584022798 Catalog Number : FG13150-1015-2X

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584022835 Catalog Number : FG13170-0615-2X

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023269 Catalog Number : FG13150-0615-2R

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023276 Catalog Number : FG13150-1015-2R

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023313 Catalog Number : FG13170-0615-2R

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023740 Catalog Number : FG13150-0615-2J

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023757 Catalog Number : FG13150-1015-2J

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023795 Catalog Number : FG13170-0615-2J

Device Description : Phenom™ 21 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023948 Catalog Number : FG15135-0615-1S

Device Description : Phenom™ 27 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584023955 Catalog Number : FG15135-1015-1S

Device Description : Phenom™ 27 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

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