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MENTOR CPX 4 Breast Tissue Expander with Suture Tabs

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name
MENTOR CPX 4 Breast Tissue Expander with Suture Tabs FDA UDI
Generic Name
Skin-port tissue expander FDA UDI
Device Name
SILTEX Tall Height Tissue Expander Style 9300, 750cc FDA UDI
Model / Reference
3549316 FDA UDI
Description
SILTEX Tall Height Tissue Expander Style 9300, 750cc FDA UDI

Identifiers

Catalog Number
354-9316 FDA UDI
Primary DI / UDI-DI
00081317006824 FDA UDI
510(k) Number
K130813 FDA UDI
FDA Product Code
LCJ FDA UDI
GMDN Term
Skin-port tissue expander FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Skin-port tissue expander

MENTOR CPX 4 Breast Tissue Expander with Suture Tabs by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-port tissue expander.

Cleared under the same submission

K130813 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 2db27341-5473-4666-a97e-be8e1e4c73e9 36 fields · synced Jun 1, 2026