A device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and
| Company | Devices | Share |
|---|---|---|
| Medi Manufacturing, Inc. | 270 | 94% |
| Pantymed S.A. | 16 | 6% |
| Dynarex Corporation | 1 | 0% |
| Synthes Gmbh | 1 | 0% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| IPM | COVER, LIMB | 361 |
| ILI | Sling, Arm | 16 |
| FXP | Cover, Shoe, Operating-Room | 1 |
Use these as the dimensions to specify in a tender line.
288 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Limb-worn device hygienic cover", from 4 companies. The largest labeler is Medi Manufacturing, Inc. with 94% of records.
IPM (COVER, LIMB), ILI (Sling, Arm), FXP (Cover, Shoe, Operating-Room)
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.