MENTOR Tissue Expander

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name: MENTOR Tissue Expander FDA UDI
Generic Name: Skin-port tissue expander FDA UDI
Device Name: Smooth Crescent, 100cc FDA UDI
Model / Reference: 3504313M FDA UDI
Description: Smooth Crescent, 100cc FDA UDI

Identifiers

Catalog Number: 350-4313M FDA UDI
Primary DI / UDI-DI: 00081317002499 FDA UDI
510(k) Number: K842883 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

Category: Skin-port tissue expander

MENTOR 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

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Mentor Texas LP

Sources (1)

FDA UDI db54f99d-0a82-432e-bf19-338b654b4074 36 fields · synced May 30, 2026