SAPI MED SPA

SAPI MED SPA

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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

Anoscope And Accessories (FER) (8) Sigmoidoscope, Rigid, Non-Electrical (KDM) (2)

Premarket Exempt

No

Clear

Anoscope - 08033638800003 Catalog Number : A.4018

Device Description : Self-Light Diagnostic Proctoscope

Device Class :

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Anoscope - 08033638800027 Catalog Number : A.4019

Device Description : Self-Light Diagnostic Proctoscope

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Anoscope - 08033638800041 Catalog Number : A.4023.1

Device Description : Self-Light Surgical Protoscope

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Anoscope - 08033638800065 Catalog Number : A.4024.1

Device Description : Self-Light Surgical Proctoscope

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Retractor - 08033638800089 Catalog Number : A.4081

Device Description : Anal retractor

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Retractor - 08033638800102 Catalog Number : A.4082

Device Description : Basile's conical anal retractor

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Retractor - 08033638800126 Catalog Number : A.4083

Device Description : The Beak Surgical proctoscope

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Retractor - 08033638800140 Catalog Number : A.4084

Device Description : The Beak Diagnostic

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Rectoscope - 08033638800164 Catalog Number : A.4113

Device Description : Proctoscope 130 mm

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : KDM

Prescription Use : Yes

Device Count : 1

Rectoscope - 08033638800188 Catalog Number : A.4120

Device Description : Pediatric rectoscope 200 mm

Device Class : 2

Duns Number: 437320088

Premarket Exempt : No

Product Code : KDM

Prescription Use : Yes

Device Count : 1

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