MENTOR TEXAS L.P.

Address:555 Airline Drive,Coppell,TX,75019,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

Expander, skin, inflatable (LCJ) (10)

Premarket Exempt

No Yes

Clear

MENTOR ARTOURA PLUS, Smooth, High Profile - 10081317028151 Catalog Number : SDC-155H

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 850cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, High Profile - 10081317028168 Catalog Number : SDC-100H

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 225cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, High Profile - 10081317028175 Catalog Number : SDC-110H

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 300cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, Ultra High Profile - 10081317028182 Catalog Number : SDC-100UH

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 350cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, High Profile - 10081317028199 Catalog Number : SDC-120H

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 375cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, Ultra High Profile - 10081317028205 Catalog Number : SDC-110UH

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 455cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, Ultra High Profile - 10081317028212 Catalog Number : SDC-120UH

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 535cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, Ultra High Profile - 10081317028229 Catalog Number : SDC-130UH

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, Ultra High Profile - 10081317028236 Catalog Number : SDC-135UH

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 700cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

MENTOR ARTOURA PLUS, Smooth, High Profile - 10081317028243 Catalog Number : SDC-130H

Device Description : Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 475cc

Device Class : U

Duns Number: 167450993

Premarket Exempt : No

Product Code : LCJ

Prescription Use : Yes

Device Count : 1

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