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 - 00081317000112 Catalog Number : 350-7350BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000129 Catalog Number : 350-7375BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 375cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000136 Catalog Number : 350-7400BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 400cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000143 Catalog Number : 350-7450BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 450cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000150 Catalog Number : 350-7500BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 500cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000167 Catalog Number : 350-7550BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 550cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000174 Catalog Number : 350-7600BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 600cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000181 Catalog Number : 350-7700BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 700cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000198 Catalog Number : 350-7800BC

Device Description : Smooth Round Moderate Profile Gel-Filled Breast Implant, 800cc

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000204 Catalog Number : 350-1001BC

Device Description : Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 100cc Smooth Roun Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 100cc 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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