BraceID-OA Knee Orthosis Single Unilateral Hinge-Right Universal

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW030

  The product should only be used in case of a medical indication or when prescribed by a physician. It should also be applied by a competent orthopedic technician. This person has also the responsibility to provide the patient accurate information about correct and safe use, according his/her individual needs. The patient should under no circumstances make any change or adjustment to the brace without the consent of physician or orthopedic technician
• CW011

  Precautions • Don’t apply the straps too tight that it interferes with circulation or that nerves experience too much compression. • If you experience pain, swelling, skin discoloration or unusual reactions while using this product, use should be discontinued and a healthcare professional consulted. • In case you have doubts about the application of the product, you should contact an orthopedic specialist (doctor or technician).
• CW262

  EUDAMED did not publish a description for this code.
• CW999

  Important information • This brace should only be applied in accordance with the instructions mentioned in this manual. • The product is intended for single patient use. • No liability is accepted for incorrect product use. • Guarantee is bound to statutory regulations.

Primary placement in Belgium; available across 1 country total.

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

Trade name

BraceID-OA Knee Orthosis Single Unilateral Hinge-Right Universal

UDI-DI code

05404020402496

Basic UDI-DI

5404020402kneehipFJ

Reference / catalog number

12-0026-2R

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

• Size: Universal Right

• Y061216HIP-KNEE ORTHOSES

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