CARGUS INTERNATIONAL, INC

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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

Material, Impression (ELW) (10)

Premarket Exempt

No Yes

Clear

MARK3 - D79611421 Catalog Number :

Device Description : eXact VPS Impression Material Medium Regular 50ml. Cartridges Set 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961142BULK1 Catalog Number :

Device Description : eXact VPS Impression Material Medium Regular 50ml. Cartridges Set 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D796114310 Catalog Number :

Device Description : eXact VPS Impression Material Medium Fast Set 50ml. Cartridges 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961143BULK1 Catalog Number :

Device Description : eXact VPS Impression Material Medium Fast Set 50ml. Cartridges 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D796114411 Catalog Number :

Device Description : eXact VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961144BULK1 Catalog Number :

Device Description : eXact VPS Impression Material Heavy Regular Set 50ml. Cartridges 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D796114512 Catalog Number :

Device Description : eXact VPS Impression Material Heavy Fast Set 50ml. Cartridges 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961145BULK1 Catalog Number :

Device Description : eXact VPS Impression Material Heavy Fast Set 50ml. Cartridges 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D796114613 Catalog Number :

Device Description : eXact VPS Impression Material Monophase Regular Set 50ml. Cartridges 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961146BULK1 Catalog Number :

Device Description : eXact VPS Impression Material Monophase Regular Set 50ml. Cartridges 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

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