BraceID-ROM Elbow Orthosis - Right

Organization name

Orthobroker

SRN

BE-MF-000000331

Manufacturer status

Active

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

• CW011

  Contra-Indications • Instable fractures of humerus, ulna or radius Precautions • Particularly during the first days after the traumatic event or surgery, the patient’s hand should be supported by an arm sling. • If unusual swelling, skin discoloration or discomfort occurs, use should be discontinued, and a healthcare professional consulted. • Be careful that the support is not so tight that it interferes with circulation. Undertake circulatory observations post-product application. • Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas • This device is meant for single patient use..
• CW030

  This orthosis is to be fitted, initially, by a healthcare professional familiar with the purpose for which it is prescribed. The healthcare professional is responsible for providing guidance to the patient.
• CW010

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

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 2 countries total.

Trade name

BraceID-ROM Elbow Orthosis - Right

UDI-DI code

05404020402380

Basic UDI-DI

5404020402shoulderelbowCA

Reference / catalog number

12-0060-2

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

• universal= 38 - 46 cm

• Y060624SHOULDER-ELBOW ORTHOSES

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