BraceID-ROM Walker - STD Liner- Large (43-46)

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW011

  Contraindications • Not intended for unstable fractures or fractures of the proximal tibia or fibula Precautions • Frequency and duration of use should be determined by your prescribing health care professional • Be careful that the support is not so tight that it interferes with circulation. • The tension of the straps could be slightly released when in resting position, or at night, to avoid circulatory or nerve compression problems.
• CW010

  The brace should only be applied in accordance with the instructions for use.
• CW262

  • The product is intended for single patient use.

Primary placement in Belgium; available across 5 countries total.

Trade name

BraceID-ROM Walker - STD Liner- Large (43-46)

UDI-DI code

05404020401239

Basic UDI-DI

5404020402anklefootAV

Reference / catalog number

12-0003-L

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

• Large = 43-46 (EU)

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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