Consulting Wallah › Device Explorer › Other devices › Wrist splint, single-use
Device Explorer · FDA GUDID · GMDN 45128

Wrist splint, single-use

A rigid external support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a proc

US‑registered devices389in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Bird & Cronin, Llc37797%
Semler Technologies, Inc.82%
O&M Halyard, Inc.21%
Innomotive L.L.C10%
Marine Polymer Technologies, Inc.10%

Top labelers

CompanyDevicesShare
Bird & Cronin, Llc37797%
Semler Technologies, Inc.82%
O&M Halyard, Inc.21%
Innomotive L.L.C10%
Marine Polymer Technologies, Inc.10%

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

Brand names on the register (sample)

QuickBraceU2 WRIST W/ THUMB UNIV PED LTU2 WRIST W/ THUMB UNIV PED RTU2 WRIST UNIV. LTU2 WRIST UNIV. RTPREMIER WRIST W/THUMB XL RTPREMIER WRIST W/THUMB LG RTPREMIER WRIST W/THUMB MD RTPREMIER WRIST W/THUMB SM RTPREMIER WRIST W/THUMB XS RTPREMIER WRIST W/THUMB XL LTPREMIER WRIST W/THUMB LG LTPREMIER WRIST W/THUMB MD LTPREMIER WRIST W/THUMB SM LTPREMIER WRIST W/THUMB XS LTPREMIER WRIST BRACE XL RT

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

FDA product codes

CodeNameDevices
IQIOrthosis, Limb Brace387
FMQRestraint, Protective8
ILHSplint, Hand, And Components2
ILHSPLINT, HAND, AND COMPONENTS2
CCXSupport, Patient Position1

GMDN & GCC registration

  • GMDN code 45128 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 2% · 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 wrist splint, single-use products are registered in the US?

389 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wrist splint, single-use", from 5 companies. The largest labeler is Bird & Cronin, Llc with 97% of records.

Which FDA product codes apply?

IQI (Orthosis, Limb Brace), FMQ (Restraint, Protective), ILH (Splint, Hand, And Components), ILH (SPLINT, HAND, AND COMPONENTS)

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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