Orthosolid-CARPI Wrist Orthosis-LONG LEFT

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW011

  Contra indications • Severe sprains • Immediate treatment following fractures Precautions • In the event of abnormal swelling, skin discolouration or the occurrence of discomfort, discontinue use and consult the healthcare provider. • The orthosis should be comfortable and snug, without disrupting blood circulation. • If the orthosis is applied over open or infected wounds, provide appropriate wound care.
• CW030

  Measurement and application must be carried out by a certified (para)medic.
• CW010

  This orthosis must be worn strictly according to the instructions for use.
• CW262

  The product is intended for use by a single patient
• CW999

  Do not place the orthosis near extremely high heat sources.

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

Orthosolid-CARPI Wrist Orthosis-LONG LEFT

UDI-DI code

05404020402991

Basic UDI-DI

5404020402wristhandZ6

Reference / catalog number

OS-302-AA

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

• The CARPI Wrist Orthosis can be modified in the online OrthoSOLID® platform in which the health care professional can adapt the design to fit the need of the patient. Product dimensions are adapted to fit a 3D scan of the patients arm.

• Y060612WRIST-HAND ORTHOSES

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