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: INTEGRA, RECTANGLE SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS FDA UDI
Model / Reference: 3610-24-2-ST FDA UDI
Description: INTEGRA, RECTANGLE SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS FDA UDI

Identifiers

Primary DI / UDI-DI: 00650551148951 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

Dimensions & Sizes

Size: Total Volume — 320 Milliliter FDA UDI
Length — 5 Centimeter FDA UDI
Width — 12 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

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

Manufacturer

Manufacturer: Pmt Corp.

Sources (1)

FDA UDI e4705c06-7f2b-430d-a04a-7b4dde906c91 36 fields · synced Jun 8, 2026