Consulting Wallah › Device Explorer › Orthoses & supports › Shoulder immobilizer/orthosis, single-use
Device Explorer · FDA GUDID · GMDN 44878

Shoulder immobilizer/orthosis, single-use

A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the

US‑registered devices86in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Bird & Cronin, Llc6373%
Trulife Limited1113%
Deroyal Industries, Inc.89%
Southern Implants (Pty) Ltd11%
Hausmann Enterprises, Llc11%
Manamed, Inc.11%
Arum Dentistry Co., Ltd.11%

Top labelers

CompanyDevicesShare
Bird & Cronin, Llc6373%
Trulife Limited1113%
Deroyal Industries, Inc.89%
Southern Implants (Pty) Ltd11%
Hausmann Enterprises, Llc11%
Manamed, Inc.11%
Arum Dentistry Co., Ltd.11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AB-COOL SHOULDER WRAP W/2,2.0 PKManaMedDeRoyalTrulifeVELPEAU IMMOBILIZER/SLING XLVELPEAU IMMOBILIZER/SLING LGVELPEAU IMMOBILIZER/SLING MDVELPEAU IMMOBILIZER/SLING SMVELPEAU IMMOBILIZER/SLING XSMESH VELPEAU SHOULDER IMMOB LGMESH VELPEAU SHOULDER IMMOB MDMESH VELPEAU SHOULDER IMMOB SMB-COOL SHOULDER COLD KITSHOULDER IMMOBILIZER UNIVB-COOL SHOULDER WRAP THERAPY KIT

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 Brace58
IMEPack, Hot Or Cold, Reusable11
IQIORTHOSIS, LIMB BRACE7
ILISLING, ARM4
IOYSUPPORT, ARM4
MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB4

GMDN & GCC registration

  • GMDN code 44878 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 10% · OTC 14%
  • 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 shoulder immobilizer/orthosis, single-use products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoulder immobilizer/orthosis, single-use", from 7 companies. The largest labeler is Bird & Cronin, Llc with 73% of records.

Which FDA product codes apply?

IQI (Orthosis, Limb Brace), IME (Pack, Hot Or Cold, Reusable), IQI (ORTHOSIS, LIMB BRACE), ILI (SLING, ARM)

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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