ARTOURA Breast Tissue Expander

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name: ARTOURA Breast Tissue Expander FDA UDI
Generic Name: Skin-port tissue expander FDA UDI
Device Name: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 350cc FDA UDI
Model / Reference: TEXP100RUH FDA UDI
Description: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 350cc FDA UDI

Identifiers

Catalog Number: TEXP100RUH FDA UDI
Primary DI / UDI-DI: 00081317009528 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Skin-port tissue expander

ARTOURA Breast Tissue Expander 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.

INTEGRA® — Pmt Corp. · U
INTEGRA® — Pmt Corp. · U
INTEGRA® — Pmt Corp. · U
INTEGRA® — Pmt Corp. · U
Dermaspan Tissue Expander — Sientra, Inc. · U
INTEGRA® — Pmt Corp. · U
INTEGRA® — Pmt Corp. · U
Softspan Tissue Expander — Sientra, Inc. · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Mentor Texas LP

Sources (1)

FDA UDI f122b345-593b-43d3-a351-9a5c24c15567 35 fields · synced Jun 8, 2026