A padded device designed to immobilize and protect an injured body extremity (arm or leg) during the healing process. It is typically in the form of a preshaped rigid mould (with padding) intended to be held in place with straps/bandages (not included); it is
| Company | Devices | Share |
|---|---|---|
| Bird & Cronin, Llc | 53 | 98% |
| Vive Health Llc | 1 | 2% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| IQI | Orthosis, Limb Brace | 53 |
| ILH | Splint, Hand, And Components | 1 |
Use these as the dimensions to specify in a tender line.
54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Padded stays splint, single-use", from 2 companies. The largest labeler is Bird & Cronin, Llc with 98% of records.
IQI (Orthosis, Limb Brace), ILH (Splint, Hand, And Components)
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.