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General| Brand | Darco |
|---|---|
| Model | OrthoWedge |
| Category | Personal Care Products |
| Language | English |
Critical warnings regarding serious incidents, adverse effects, and proper usage.
Explains the shoe is for off-loading surgery and protecting the forefoot.
Lists conditions for use like hallux valgus surgery and forefoot ulcerations, and contraindications.
Details the shoe's construction: padded ankle support, special sole for forefoot relief, and secure fasteners.
Lists compatible accessories like insoles and other shoes for combined use.
Instructions on how to open, step into, position, and close the shoe securely.
Details on available sizes, materials used for outsole, insole, upper, and straps, and color.
Information on how the product's lifespan is determined by wear and tear and prescribed usage duration.
Guidance on product maintenance requirements and instructions for cleaning the shoe.
Instructions for disposing of the product and its packaging in an environmentally friendly manner.
Identifies the product as a Medical Device and lists importer information in multiple languages.
Provides UDI information and details on single-patient, multiple-use applicability.
Lists contact information for DARCO International and DARCO (Europe) GmbH, and indicates 'Made in China'.
