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 - 00081317000013 Catalog Number : 350-7100BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000020 Catalog Number : 350-7125BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000037 Catalog Number : 350-7150BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000044 Catalog Number : 350-7175BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000051 Catalog Number : 350-7200BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000068 Catalog Number : 350-7225BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000075 Catalog Number : 350-7250BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000082 Catalog Number : 350-7275BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000099 Catalog Number : 350-7300BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

MENTOR MemoryGel Breast Implant - 00081317000105 Catalog Number : 350-7325BC

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

Device Class : 3

Duns Number: 167450993

Premarket Exempt : No

Product Code : FTR

Prescription Use : Yes

Device Count : 1

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