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MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name
MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer FDA UDI
Generic Name
Invasive breast implant sizer, fixed, single-use FDA UDI
Device Name
CONTOUR PROFILE Saline Breast Implant Sizer, 350cc FDA UDI
Model / Reference
351-0712SZ FDA UDI
Description
CONTOUR PROFILE Saline Breast Implant Sizer, 350cc FDA UDI

Identifiers

Catalog Number
351-0712SZ FDA UDI
Primary DI / UDI-DI
00081317002994 FDA UDI
510(k) Number
K010709 FDA UDI
FDA Product Code
MRD FDA UDI
GMDN Term
Invasive breast implant sizer, fixed, single-use FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010709 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mentor Texas LP

Sources (1)

  • FDA UDI 73de8321-ce05-4b08-baff-63b867c357ce 37 fields · synced May 30, 2026