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AlloX2 Tissue Expander

FDA UDI

Class U (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name
AlloX2 Tissue Expander FDA UDI
Generic Name
Skin-port tissue expander FDA UDI
Device Name
Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 340-420 cc FDA UDI
Model / Reference
AlloX2-13SE FDA UDI
Description
Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 340-420 cc FDA UDI

Identifiers

Catalog Number
AlloX2-13SE FDA UDI
Primary DI / UDI-DI
00812790028320 FDA UDI
510(k) Number
K140383 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

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

AlloX2 Tissue Expander by Sientra, Inc. — 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

K140383 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sientra, Inc.

Sources (1)

  • FDA UDI 9c3c8f8e-3f04-41f3-8286-e01baed1d28d 37 fields · synced Jun 8, 2026