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 - D79602181 Catalog Number :

Device Description : Bite Registration Regular Set 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960218449 Catalog Number :

Device Description : Bite Registration Regular Set 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7960218BULK1 Catalog Number :

Device Description : Bite Registration Regular Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602191 Catalog Number :

Device Description : Bite Registration Fast Set 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D796021944 Catalog Number :

Device Description : Bite Registration Fast Set 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7960219BULK1 Catalog Number :

Device Description : Bite Registration Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602201 Catalog Number :

Device Description : Bite Registration Super Fast Set 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960220442 Catalog Number :

Device Description : Bite Registration Super Fast Set 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7960220BULK1 Catalog Number :

Device Description : Bite Registration Super Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602211 Catalog Number :

Device Description : Bite Registration Hard Bite Fast Set 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

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