NEOPRENE SHOULDER STRAP

Organization name

PHYTO PERFORMANCE ITALIA SRL

SRN

IT-MF-000008118

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  neoprene may cause allergic reactions of the skin. If rash develops discontinue use and consult a physician. In case of circulatory problems use it under medical supervision. Do not use the band while sleeping. To be used under adult supervision for minors under 14 years of age.

Primary placement in Italy; available across 1 country total.

Trade name

NEOPRENE SHOULDER STRAP

UDI-DI code

08031255038571

Basic UDI-DI

80312550009K4

Reference / catalog number

P3011

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

The neoprene shoulder brace for compression is indicated in cases of shoulder instability and dislocation, equipped with a practical adjustable Velcro closure. One size fits all for both right and left shoulder. Washing instructions: After each use, hand wash in cold water with mild soap or detergent. Allow to dry completely. Do not tumble dry or iron. Notice: The user is required to report any incident and/or serious incident that may occur in relation to the device to both the manufacturer and the competent authority of the Member State where the user and/or patient is established. The shelf life of this medical device depends on the frequency of use, if used daily it is 2 years.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y090612ARM AND ELBOW PROTECTIONS