605988

Organization name

Focal Meditech BV

SRN

NL-MF-000000536

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 5 countries total.

Trade name

not provided

UDI-DI code

08719327649459

Basic UDI-DI

87193276494FOCPA1PC

Reference / catalog number

605988

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 basic version of Papillon consists of three pads and a base. The three individually adaptable support pads are designed to suit heads with a diversity of shapes. The two elongated, waveshaped pads (the so called sub-occipital support pads) offer support under the ear and along the base of the head. This shape gives a good deal of comfort and, because they are somewhat funnel-shaped, the pads cushion the head. On the other hand, however, the head can be easily tilted if you want to adopt a more forward posture. Whilst support is more or less automatic, it’s not always necessary. The ends of the sub-occipital support pads, which come in Small, Medium or Large versions, curve noticeably outwards. Their shape is to ensure that the head of the user doesn’t get stuck behind the head support. The third pad is the so-called occipital support pad, which occupies a higher position to support the back of the head. This pad provides extra support behind the head and acts as a safety measure to any backward movement of the head. The occipital pad should not allow the head of the user to be pressed forwards from the sub-occipital support pads. Together, the three pads, if mounted correctly should leave the ears and the shoulders free.

Additional information URL

https://www.focalmeditech.nl/papillon/

Clinical sizes

No clinical sizes registered for this device.

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

• Y181899SUPPORT SYSTEMS - OTHER