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

No Yes

Clear

MENTOR MemoryGel Breast Implant - 00081317000310 Catalog Number : 350-3751BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 375cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 375cc 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 - 00081317000327 Catalog Number : 350-4001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 400cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 400cc 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 - 00081317000334 Catalog Number : 350-4501BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 450cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 450cc 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 - 00081317000341 Catalog Number : 350-5001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 500cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 500cc 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 - 00081317000358 Catalog Number : 350-5501BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 550cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 550cc 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 - 00081317000365 Catalog Number : 350-6001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 600cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 600cc 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 - 00081317000372 Catalog Number : 350-7001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 700cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 700cc 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 - 00081317000389 Catalog Number : 350-8001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 800cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 800cc 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 - 00081317000396 Catalog Number : 350-1254BC

Device Description : Smooth Round High 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 - 00081317000402 Catalog Number : 350-1504BC

Device Description : Smooth Round High 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

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