Consulting Wallah › Device Explorer › Procedure kits & trays › Patient positioning foam mould kit
Device Explorer · FDA GUDID · GMDN 40894

Patient positioning foam mould kit

A collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould

US‑registered devices125in commercial distribution
Companies5labelers on GUDID
Single‑use21%of device records
Sterile0%labelled sterile
Prescription21%Rx‑only share
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Share of device records

Klarity Medical Products, Llc9576%
Medtec, Inc.2016%
Essebi Medical Srl65%
Cdr Systems Inc22%
Qfix22%

Top labelers

CompanyDevicesShare
Klarity Medical Products, Llc9576%
Medtec, Inc.2016%
Essebi Medical Srl65%
Cdr Systems Inc22%
Qfix22%

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

Brand names on the register (sample)

AccuForm™ CushionPediatric Cushion GuidePediatric Registration FilmAccuForm™ ShimCushion GuideRegistration FilmRediFoam™AccuForm™ PositionerKLARITY MEDICALKlarity MedicalInstaformAdapt-It™TOTIM Patient Cushion Immobilization System

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

FDA product codes

CodeNameDevices
IYEAccelerator, Linear, Medical104
IYEAccelerator, linear, medical25
LNHSystem, nuclear magnetic resonance imaging13
IXQTable, radiographic, stationary top1

GMDN & GCC registration

  • GMDN code 40894 · non‑implantable
  • Single‑use 21% · sterile 0% · Rx‑only 21% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 4Length (Centimeter) · 3Width (Centimeter) · 3

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

No closely related category with 50+ devices.

How many patient positioning foam mould kit products are registered in the US?

125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient positioning foam mould kit", from 5 companies. The largest labeler is Klarity Medical Products, Llc with 76% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), IYE (Accelerator, linear, medical), LNH (System, nuclear magnetic resonance imaging), IXQ (Table, radiographic, stationary top)

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.

How do I get quotes?

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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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