BraceID-High Regular Walker-STD Liner-Small (36-39)

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW030

  EUDAMED did not publish a description for this code.
• CW262

  The product is intended for single patient use
• 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. • The brace should not be prescribed for patients with impaired sensations. • Do not over-inflate air chamber nor over-tighten Velcro straps. These may compromise blood circulation and cause significant skin irritation, especially if used for people with diabetic neuropathy. Frequently perform circulation checks. In case of any skin discoloration or feelings of discomfort, deflate air chamber to a comfortable level. Consult your health care provider immediately if discomfort persists. • In high altitude conditions, the air chambers will expand beyond optimal level. Adjust the compression level by deflating the air chambers or loosening the Velcro straps. • Use caution when walking on a slippery or wet surface to avoid injury
• CW010

  The brace should only be applied in accordance with the instructions for use.

Primary placement in Belgium; available across 6 countries total.

Trade name

BraceID-High Regular Walker-STD Liner-Small (36-39)

UDI-DI code

05404020401550

Basic UDI-DI

5404020402anklefootAV

Reference / catalog number

12-0001-S

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

• Small= 36-39 (EU)

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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