Eu Mdr Eu Md Class 1 On The Market

SDO® Gauntlet to below elbow with 0 - 4 panels

Devices (same UDI-DI)
51
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05060598933628
Basic UDI-DI Code
506059893TF60007B
Reference
SDO13
Device Types
Single use
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Medigarments Ltd

Additional Description

The SDO® made-to-measure Advanced Gauntlet to below elbow is a dynamic Lycra® gauntlet to resist/assist wrist extension whilst stabilising the thumb in functional extension and abduction. The choice of panels (0-4) can be added which are determined by the clinician depending on the clinical reasoning for this provision.

CND Nomenclature Codes

Code Description
Y060609 WRIST (FOREARM) ORTHOSES

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The Basic UDI-DI associated with this device has 51 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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