BraceID-SHORT Regular Walker - Xlarge

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW011

  Contraindications • Not intended for unstable fractures or fractures of the prox-imal tibia or fibula Precautions & Warnings • This device should be prescribed by a qualified health care professional who also determines frequency and duration of use. • It should not be prescribed for patients with impaired sensations. • Do not over-tighten Velcro straps. These may compromise blood circulation and cause significant skin irritation, espe-cially if used for people with diabetic neuropathy. Frequently perform circulation checks. In case of any skin discoloration or feelings of discomfort consult your health care provider immediately if discomfort persists. • Use caution when walking on a slippery or wet surface to avoid injury.
• CW030

  EUDAMED did not publish a description for this code.
• CW010

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

  The product is intended for use by a single patient.

Primary placement in Belgium; available across 7 countries total.

Trade name

BraceID-SHORT Regular Walker - Xlarge

UDI-DI code

05404020499991

Basic UDI-DI

5404020402anklefootAV

Reference / catalog number

12-0016-XL

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

• X-Large= (+46) EU

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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