MEDTRONIC 3F THERAPEUTICS, 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

heart-valve, non-allograft tissue (LWR) (8) HOLDER, HEART-VALVE, PROSTHESIS (DTJ) (2)

Premarket Exempt

No Yes

Clear

3f® - 00613994961617 Catalog Number :

Device Description : THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00613994961624 Catalog Number :

Device Description : THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072503 Catalog Number :

Device Description : THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072510 Catalog Number :

Device Description : THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072527 Catalog Number :

Device Description : THV 1000-25 3F AORTIC BIO 25MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072534 Catalog Number :

Device Description : THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072541 Catalog Number :

Device Description : THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

3f® - 00643169072558 Catalog Number :

Device Description : THV 1000-29 3F AORTIC BIO 29MM 1 EA US

Device Class : 3

Duns Number: 079527232

Premarket Exempt : No

Product Code : LWR

Prescription Use : Yes

Device Count : 1

NA - 00763000137885 Catalog Number :

Device Description : TOOL 7686 HANDLE ANNULOPLASTY 29L

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

NA - 00763000137892 Catalog Number :

Device Description : TOOL 7686XL HANDLE ANNULOPLASTY 29L

Device Class : 1

Duns Number: 079527232

Premarket Exempt : Yes

Product Code : DTJ

Prescription Use : No

Device Count : 1

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