Allura

FDA UDI

Class U (US FDA UDI)

by Pmt Corp.

Identity

Trade Name: ALLURA FDA UDI
Generic Name: Skin-port tissue expander FDA UDI
Device Name: VAGINAL STENT, CYLINDRICAL, 4 SUTURE TABS, 4X12CM, 145CC FILL FDA UDI
Model / Reference: 3321-12-N FDA UDI
Description: VAGINAL STENT, CYLINDRICAL, 4 SUTURE TABS, 4X12CM, 145CC FILL FDA UDI

Identifiers

Primary DI / UDI-DI: 00650551000914 FDA UDI
510(k) Number: K845036 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Skin-port tissue expander

Allura by Pmt Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-port tissue expander.

MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP · U
Dermaspan Tissue Expander — Sientra, Inc. · U
Softspan Tissue Expander — Sientra, Inc. · U
Natrelle 133S Tissue Expanders — Allergan · U
Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A. · U
Softspan Tissue Expander — Sientra, Inc. · U
AlloX2 Tissue Expander — Sientra, Inc. · U
Softspan Tissue Expander — Sientra, Inc. · U

Cleared under the same submission

K845036 also covers:

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: Pmt Corp.

Sources (1)

FDA UDI cce28718-22df-4516-a5d6-8ef4d232bf6b 34 fields · synced May 30, 2026