BIOSTABLE ENGINEERING & SCIENCE

BIOSTABLE ENGINEERING & SCIENCE

Address:2621 Ridgepoint Dr SUITE100,Austin,TX,78754,US

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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

Aortic Annuloplasty Ring (PST) (8) Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (1)

Premarket Exempt

No

Clear

HAART - 10857160006239 Catalog Number : 200-19US

Device Description : Aortic Annuloplasty Ring

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006246 Catalog Number : 200-21US

Device Description : Aortic Annuloplasty Device

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006253 Catalog Number : 200-23US

Device Description : Aortic Annuloplasty Device

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006260 Catalog Number : 200-25US

Device Description : Aortic Annuloplasty Device

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006277 Catalog Number : 300-19US

Device Description : Aortic Annuloplasty Ring

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006284 Catalog Number : 300-21US

Device Description : Aortic Annuloplasty Device

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006291 Catalog Number : 300-23US

Device Description : Aortic Annuloplasty Ring

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART - 10857160006307 Catalog Number : 300-25US

Device Description : Aortic Annuloplasty Ring

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : PST

Prescription Use : Yes

Device Count : 1

HAART Polyester Pledget 6-Pack - 10857160006338 Catalog Number : 100-06US

Device Description : Polyester pledgets for use with HAART Aortic Annuloplasty Devices

Device Class : 2

Duns Number: 012321281

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

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