REVMEDX, INC.

Address:25999 SW CANYON CREEK RD STE C,Wilsonville,OR,97070,US

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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

Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use (PGZ) (3) Gauze / Sponge,Nonresorbable For External Use (NAB) (1)

Premarket Exempt

Clear

XSTAT - 00851587006042 Catalog Number : FIN-0001-04

Device Description : A hemostatic device for severe bleeding. Each device comprises approximately 38 A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked with an X-shaped radiopaque marker.

Device Class :

Duns Number: 961523441

Premarket Exempt : No

Product Code : PGZ

Prescription Use : Yes

Device Count : 1

XSTAT - 00851587006059 Catalog Number : FIN-0001-03

Device Description : A hemostatic device for severe bleeding. Each device comprises approximately 92 A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker.

Device Class : 2

Duns Number: 961523441

Premarket Exempt : No

Product Code : PGZ

Prescription Use : Yes

Device Count : 1

XSTAT - 00851587006066 Catalog Number : FIN-0017-01

Device Description : A hemostatic device for severe bleeding. Each device comprises approximately 108 A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked with an X-shaped radiopaque marker.

Device Class :

Duns Number: 961523441

Premarket Exempt : No

Product Code : NAB, PGZ

Prescription Use : Yes

Device Count : 1

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