Consulting Wallah › Device Explorer › Other devices › Wrist splint, reusable
Device Explorer · FDA GUDID · GMDN 12102

Wrist splint, reusable

A rigid external support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such

US‑registered devices94in commercial distribution
Companies8labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Elite Orthopaedics, Inc.3436%
Vive Health Llc2628%
Md Orthopaedics, Inc.1415%
Manamed, Inc.66%
Ideavillage Products Corp66%
Pantymed S.A.55%
Princeton Medical Group, Inc.22%
Wal-Mart Stores, Inc.11%

Top labelers

CompanyDevicesShare
Elite Orthopaedics, Inc.3436%
Vive Health Llc2628%
Md Orthopaedics, Inc.1415%
Manamed, Inc.66%
Ideavillage Products Corp66%
Pantymed S.A.55%
Princeton Medical Group, Inc.22%
Wal-Mart Stores, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ManaMedElite OrthopaedicsCopperfitPRINCETONManaEZ Wrist Right, Extra SmallManaEZ Wrist Right, Extra LargeManaEZ Wrist Left, Extra SmallManaEZ Wrist Left, Extra LargeRhinoViveCoretechVIVECoreTechEquateWELLBRACE

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

FDA product codes

CodeNameDevices
ILHSplint, Hand, And Components54
IOYSupport, Arm14
ITQJoint, Knee, External Brace12
IPGShoe, Cast11
MDMInstrument, Manual, Surgical, General Use2
ITWJoint, Ankle, External Brace1

GMDN & GCC registration

  • GMDN code 12102 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 1% · OTC 50%
  • 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, reusable products are registered in the US?

94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wrist splint, reusable", from 8 companies. The largest labeler is Elite Orthopaedics, Inc. with 36% of records.

Which FDA product codes apply?

ILH (Splint, Hand, And Components), IOY (Support, Arm), ITQ (Joint, Knee, External Brace), IPG (Shoe, Cast)

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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