GENESEE BIOMEDICAL, INC.

Address:700 W Mississippi Ave Unit D5,DENVER,CO,80223,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

Ring, Annuloplasty (KRH) (10)

Premarket Exempt

No Yes

Clear

FlexForm Annuloplasty Band - B040FBH280 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH300 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH320 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH340 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH360 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH380 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBH400 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBN240 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBN260 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

FlexForm Annuloplasty Band - B040FBN280 Catalog Number :

Device Description : Annuloplasty Band

Device Class : 2

Duns Number: 939872651

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

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