SACRED HEART MEDICAL,INC.

SACRED HEART MEDICAL,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

Dislodger, Stone, Basket, Ureteral, Metal (FFL) (9) Dislodger, Stone, Biliary (LQR) (1)

Premarket Exempt

No Yes

Clear

Summit - B0323425150 Catalog Number : 342515

Device Description : 3.0 Fr, 90 cm, Stainless Steel Flat Wire Stone Basket with Filiform Tip

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Biliary Stone Basket - B032500240 Catalog Number : 50024

Device Class : 2

Duns Number: 832763002

Premarket Exempt : No

Product Code : LQR

Prescription Use : No

Device Count : 1

Hercules - B0325305200 Catalog Number : 530520

Device Description : 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Hercules - B0325305250 Catalog Number : 530525

Device Description : 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket with Filiform Tip

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Apex - B0325443100 Catalog Number : 544310

Device Description : 2.4 Fr, 90 cm, NiTi Flat Wire Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Apex - B0325443200 Catalog Number : 544320

Device Description : 2.4 Fr, 120 cm, NiTi Flat Wire Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Vantage - B0325503100 Catalog Number : 550310

Device Description : 2.4 Fr, 90 cm, NiTi Tipless Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Vantage - B0325503200 Catalog Number : 550320

Device Description : 2.4 Fr, 120 cm, NiTi Tipless Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

Halo - B0325541200 Catalog Number : 554120

Device Description : 1.5 Fr, 120 cm, NiTi Tipless Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

6-Wire Halo - B0325561600 Catalog Number : 556160

Device Description : 1.5 Fr, 120 cm, 6-Wire NiTi Tipless Stone Basket

Device Class : 2

Duns Number: 832763002

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : No

Device Count : 1

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