DAS Medical International SRL

DAS Medical International SRL

Address:Industrial Free Zone II,La Romana,DO

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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

Drape, Surgical, Exempt (PUI) (9) Table, Cysto, Non-Electrical (EYH) (1)

Premarket Exempt

Yes

Clear

TransEnterix - 07466532979017 Catalog Number : X9007635

Device Description : Senhance Manipulator Drape 1-PK X9007635

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

TransEnterix - 07466532979024 Catalog Number : X9007636

Device Description : Senhance Manipulator Drape 3-PK X9007636

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

DAS - 07466532979031 Catalog Number : SPD-18-001

Device Description : Lateral and Prone Access Drape SPD-18-001

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

TranEnterix - 07466532979048 Catalog Number : X0008236

Device Description : Sterile Tape X0008236

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

TransEnterix - 07466532979055 Catalog Number : X0007790

Device Description : Senhance Articulating Drape X0007790

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

TransEnterix - 07466532979062 Catalog Number : X9007669

Device Description : Senhance Articulating Drape X9007669

Device Class :

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

Schaerer - 07466532979116 Catalog Number : 71107

Device Description : Urology Drain Bag

Device Class : 1

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : EYH

Prescription Use : Yes

Device Count : 1

Schaerer - 07466532979130 Catalog Number : 10607

Device Description : Patient Isolation Drape

Device Class : 2

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

Proteger - 07466532979147 Catalog Number : ZP6553120

Device Description : Zeiss 65D Surgical Protection System 53" X 120" (ZP6553120)

Device Class : 2

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

Proteger - 07466532979178 Catalog Number : LP6853120

Device Description : Leica 68D Surgical Protection System 53" X 120" (LP6853120)

Device Class : 2

Duns Number: 817435655

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

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