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Device Explorer · FDA GUDID · GMDN 61522

Funnel chest remodelling bar

A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically

US‑registered devices5,220in commercial distribution
Companies5labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Microfixation, Inc4,69290%
L&K Biomed Co. ,Ltd.3076%
Gm Dos Reis Industria E Comercio Ltda1052%
Kls-Martin L.P.601%
Jeil Medical Corporation561%

Top labelers

CompanyDevicesShare
Biomet Microfixation, Inc4,69290%
L&K Biomed Co. ,Ltd.3076%
Gm Dos Reis Industria E Comercio Ltda1052%
Kls-Martin L.P.601%
Jeil Medical Corporation561%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Pectus Blu (TM)PECTUS BLU (TM)PECTUS SYSTEMN/APECTUS SUPPORT BARIPSPURE PECTUSPECTUS SYSTEMPS-0820CastleLoc Pectus Bar SystemARIX Pectus Bar SystemPectus Versa System

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

FDA product codes

CodeNameDevices
HRSPlate, Fixation, Bone5,031
HRSPlate, fixation, bone172
HRSPLATE, FIXATION, BONE88

GMDN & GCC registration

  • GMDN code 61522 · implantable
  • Single‑use 99% · sterile 0% · Rx‑only 94% · 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

No structured size data on the register.

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

How many funnel chest remodelling bar products are registered in the US?

5,220 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Funnel chest remodelling bar", from 5 companies. The largest labeler is Biomet Microfixation, Inc with 90% of records.

Which FDA product codes apply?

HRS (Plate, Fixation, Bone), HRS (Plate, fixation, bone), HRS (PLATE, FIXATION, BONE)

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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