DANVILLE MATERIALS, LLC

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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

FUSION - 00816594023727 Catalog Number : FZA

Device Description : FUSION,VPS,ZERO-ALGIN,50ML

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FUSION - 00816594023734 Catalog Number : FMSA

Device Description : FUSION,FS,MONO,SUPER,ALEG.

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FUSION - 00816594023741 Catalog Number : FHA

Device Description : FUSION,FS,HVY,BODY,ALEGRO,6PK

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FUSION - 00816594023758 Catalog Number : FHA1

Device Description : FUS.FS,HVY,BDY,ALEGRO,50ML

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROYAL - 00816594023765 Catalog Number : 81016

Device Description : OEM,ROYAL,CART,FS,MED.BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROYAL - 00816594023772 Catalog Number : 81000

Device Description : OEM,ROYAL,CART.HEAVY,BDY,FS

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROYAL - 00816594023789 Catalog Number : 81001

Device Description : OEM,ROYAL,CART.LIGHT,BDY,FS

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

VIAX - 00816594023796 Catalog Number : 94945

Device Description : VIAX,BITE,REGISTRATION,2PK

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

VIAX - 00816594023819 Catalog Number : 94943

Device Description : VIAX,HVY.BODY,FS,4PK

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

VIAX - 00816594023826 Catalog Number : 94944

Device Description : VIAX,HVY.BODY,RS,4PK

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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