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Device Explorer · FDA GUDID · GMDN 45187

Skin-port tissue expander

An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision o

US‑registered devices1,719in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Pmt Corporation1,29075%
Sientra, Inc.19411%
Mentor Texas L.P.16410%
Allergan, Inc.362%
Osmed Gmbh201%
Establishment Labs S.A.151%

Top labelers

CompanyDevicesShare
Pmt Corporation1,29075%
Sientra, Inc.19411%
Mentor Texas L.P.16410%
Allergan, Inc.362%
Osmed Gmbh201%
Establishment Labs S.A.151%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Flora™ Tissue Expander SMOOTHSILK®SIENTRA Dual Magnetic Port LocatorWinged Needle Infusion SetSoftspan Tissue ExpanderDermaspan Tissue ExpanderAlloX2 Tissue ExpanderIntegraINTEGRAINTEGRA®REALM®N/AACCUSPAN®ALLURAMentor CPX4 with suture tabs, tall height, smootMentor CPX4 with suture tabs, med height, smoothMentor CPX4 with suture tabs, low height, smooth

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LCJExpander, Skin, Inflatable1,957
LCJEXPANDER, SKIN, INFLATABLE147
LCJTissue Expander And Accessories117
LCJExpander, skin, inflatable33
LCJTissue expander and accessories23
NFMExpander, Tissue, Orbital20

GMDN & GCC registration

  • GMDN code 45187 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 1,391Length (Centimeter) · 1,109Total Volume (Centiliter) · 1,031Total Volume (Milliliter) · 145Length (Millimeter) · 2Balloon Diameter (Centimeter) · 2

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many skin-port tissue expander products are registered in the US?

1,719 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin-port tissue expander", from 6 companies. The largest labeler is Pmt Corporation with 75% of records.

Which FDA product codes apply?

LCJ (Expander, Skin, Inflatable), LCJ (EXPANDER, SKIN, INFLATABLE), LCJ (Tissue Expander And Accessories), LCJ (Expander, skin, inflatable)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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