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Dermaspan Tissue Expander

FDA UDI

Class U (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name
Dermaspan Tissue Expander FDA UDI
Generic Name
Skin-port tissue expander FDA UDI
Device Name
Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 460-550 cc FDA UDI
Model / Reference
LPP14S FDA UDI
Description
Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 460-550 cc FDA UDI

Identifiers

Catalog Number
LPP14S FDA UDI
Primary DI / UDI-DI
00812790028788 FDA UDI
510(k) Number
K070303 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

Dermaspan 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

K070303 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 57437c22-1552-40ba-9dca-320514600726 37 fields · synced May 31, 2026