MENTOR TEXAS L.P.

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

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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

Prosthesis, breast, noninflatable, internal, silicone gel-filled (FTR) (10)

Premarket Exempt

Yes No

Clear

MENTOR MemoryGel Breast Implant - 00081317000211 Catalog Number : 350-1251BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 125cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 125cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000228 Catalog Number : 350-1501BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 150cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 150cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000235 Catalog Number : 350-1751BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 175cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 175cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000242 Catalog Number : 350-2001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 200cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 200cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000259 Catalog Number : 350-2251BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 225cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 225cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000266 Catalog Number : 350-2501BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 250cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 250cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000273 Catalog Number : 350-2751BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 275cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 275cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000280 Catalog Number : 350-3001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 300cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 300cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000297 Catalog Number : 350-3251BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 325cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 325cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000303 Catalog Number : 350-3501BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 350cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 350cc Smooth Round Silicone

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

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