BANDAGES - OTHER (see Y06 for collars, tutors, etc.)

Primary DI

08800106200005

Basic UDI-DI Code

88001062FSCUU

Reference

FS2003

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

SURGINUS Co., Ltd.

The device is composed of a pair of flexible plastic (PET) patches coated on one side with a hydrocolloid adhesive, which are connected to each other by an adjustable closing mechanism using nylon straps. It is used to approximate the edges of surgical incision, cut or laceration, or to protect and assist recovery of suture site by distributing the strain of the suture to wider area. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing up to 4 weeks. The device can be removed by lifting one edge, wetting hydrocolloids with alcohol swab, and peeling the device from the skin. The device is a single-use device, provided sterile in an intact and sealed package. 7 different variants in length from 32 mm to 255 mm are available.

The Basic UDI-DI associated with this device has 7 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).