Integra®

FDA UDI

Class U (US FDA UDI)

by Pmt Corp.

Identity

Trade Name: INTEGRA® FDA UDI
Generic Name: Skin-port tissue expander FDA UDI
Device Name: TISSUE EXPANDER, ROUND, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS FDA UDI
Model / Reference: 3612ES-02-IR-ST FDA UDI
Description: TISSUE EXPANDER, ROUND, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS FDA UDI

Identifiers

Catalog Number: 3612ES-02-IR-ST FDA UDI
Primary DI / UDI-DI: 00650551101734 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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 350 Centiliter FDA UDI
Length — 10 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

Category: Skin-port tissue expander

Integra® 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 2189d8f4-d545-49f4-a0b1-a0cc3d9a772c 38 fields · synced May 31, 2026