Angiomed GmbH & Co. Medizintechnik KG

Address:WACHHAUSSTRASSE 6,KARLSRUHE Baden-Wurttemberg,DE

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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, BILIARY, DIAGNOSTIC (FGE) (8) NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (2)

Premarket Exempt

No Yes

Clear

VACU-CUT® - 00801741083907 Catalog Number : 17640070

Device Description : VACU-CUT® Disposable Aspiration Biopsy Needle 18g x 150mm

Device Class : 1

Duns Number: 320047483

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

VACU-CUT® - 00801741083914 Catalog Number : 17640080

Device Description : VACU-CUT® Disposable Aspiration Biopsy Needle 18g x 200mm

Device Class : 1

Duns Number: 320047483

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099236 Catalog Number : LXB08040

Device Description : Flexxus® Endoscopic Biliary Stent, 8 mm x 40 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099243 Catalog Number : LXB08060

Device Description : Flexxus® Endoscopic Biliary Stent, 8 mm x 60 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099250 Catalog Number : LXB08080

Device Description : Flexxus® Endoscopic Biliary Stent, 8 mm x 80 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099267 Catalog Number : LXB08100

Device Description : Flexxus® Endoscopic Biliary Stent, 8 mm x 100 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099274 Catalog Number : LXB10040

Device Description : Flexxus® Endoscopic Biliary Stent, 10 mm x 40 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099281 Catalog Number : LXB10060

Device Description : Flexxus® Endoscopic Biliary Stent, 10 mm x 60 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099298 Catalog Number : LXB10080

Device Description : Flexxus® Endoscopic Biliary Stent, 10 mm x 80 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Flexxus® Endoscopic Biliary Stent - 00801741099304 Catalog Number : LXB10100

Device Description : Flexxus® Endoscopic Biliary Stent, 10 mm x 100 mm (190cm deployment system)

Device Class : 2

Duns Number: 320047483

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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