BraceID-Ortho Wedge Shoe-Left/ Right-Extra Small

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW030

  The device should be prescribed by a qualified health care professional who also determines frequency and duration of use.
• CW999

  Not intended for unstable or open fractures.
• CW011

  • Be careful with patients having impaired sensations. In case of pain or swelling, discontinue use and consult your medical provider immediately. • Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas. • Use caution when walking on a slippery or wet surface to avoid injury. • Do not drive a vehicle while you are wearing this device.
• CW010

  This brace should only be applied in accordance with the instructions mentioned in this manual.
• CW262

  The product is intended for single patient use.

Primary placement in Belgium; available across 2 countries total.

Trade name

BraceID-Ortho Wedge Shoe-Left/ Right-Extra Small

UDI-DI code

05404020410002

Basic UDI-DI

5404020402anklefootAV

Reference / catalog number

12-1009-XS

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Extra-Small= XS= Shoe size 35-37

• Y063303READY-MADE ORTHOTIC SHOES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification