Consulting Wallah › Device Explorer › Other devices › Freestanding headrest, reusable
Device Explorer · FDA GUDID · GMDN 58080

Freestanding headrest, reusable

A device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attach

US‑registered devices130in commercial distribution
Companies12labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Deroyal Industries, Inc.3728%
Steris Corporation3124%
Action Products, Inc.2519%
Imris Imaging, Inc.129%
Mizuho Orthopedic Systems, Inc.65%
Soule Co., The54%
Oakworks, Inc.43%
Mercury Enterprises, Inc.43%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.3728%
Steris Corporation3124%
Action Products, Inc.2519%
Imris Imaging, Inc.129%
Mizuho Orthopedic Systems, Inc.65%
Soule Co., The54%
Oakworks, Inc.43%
Mercury Enterprises, Inc.43%
Casco Manufacturing Solutions, Inc.22%
Southmedic Incorporated22%
Sunmed, Llc11%
Airlife11%

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

Brand names on the register (sample)

Horseshoe HeadrestVISIUSeye"HEAD RING, GEL, ADULT, OPEN, 8.0"" DIAM""HEAD RING, GEL, PED, OPEN, 3.5"" DIAM""HEAD RING, GEL, ADOL, CLOSED, 5.5"" DIAM""HEAD RING, GEL, PED, CLOSED, 3.5"" DIA""HEAD RING, GEL, ADOL, OPEN, 5.5"" DIAM"CLOSED GEL HEAD RING, ADULTOakworks MedicalCMATTSoule MedicalDeRoyalVizient NovaplusNABirkovaAction®

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

FDA product codes

CodeNameDevices
CCXSUPPORT, PATIENT POSITION39
HBMHEADREST, NEUROSURGICAL25
FMPProtector, Skin Pressure25
CCXSupport, Patient Position20
HBMHeadrest, Neurosurgical6
FTYTape, Measuring, Rulers And Calipers6

GMDN & GCC registration

  • GMDN code 58080 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 44% · OTC 12%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 1Width (Inch) · 1Height (Inch) · 1

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

How many freestanding headrest, reusable products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Freestanding headrest, reusable", from 12 companies. The largest labeler is Deroyal Industries, Inc. with 28% of records.

Which FDA product codes apply?

CCX (SUPPORT, PATIENT POSITION), HBM (HEADREST, NEUROSURGICAL), FMP (Protector, Skin Pressure), CCX (Support, Patient Position)

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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