Sterile incise film

SoFilm is a sterile incision film consisting of a transparent polyurethane film single coated with a pressure- and temperature-sensitive adhesive and supplied with a 120 grams release liner and a 5cm wide transparent finger lift. SoFilm is resistant to water, body fluids, detergents and alcohol. SoFilm is individually wrapped, pouched and sterilised by EO

Intended use
SoFilm is intended to be applied on the patient’s skin for covering and protecting during surgical interventions. The incision is made through the film.

Certification
SoFilm is a medical device and a CE mark is placed on the products’ packaging. A declaration of conformity of the manufacturer that the product meets all of the requirements of the Medical Devices Directive (MDD 93/42/EEC) is available upon request.

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Product nameProduct code Dimensions
SoFilm 25x20 (60 pouches in a box)305001GBZSME 25cm (A) x 20cm (B) | 2x 5cm FL | folded | sterile
SoFilm 50x35 (30 pouches in a box)305003GBZSME 50cm (A) x 35cm (B) | 2x 5cm FL | folded | sterile
SoFilm 50x45 (30 pouches in a box)305004GBZSME 50cm (A) x 45cm (B) | 2x 5cm FL | folded | sterile
SoFilm 65x45 (30 pouches in a box)305005GBZSME 65cm(A) x 45cm (B) | 2x 5cm FL | folded | sterile
SoFilm 65x60 (30 pouches in a box)305006GBZSME 65cm (A) x 60cm (B) | 2x 5cm FL | folded | sterile
SoFilm 65x85 (30 pouches in a box)305011GBZSME 65cm(A) x 85cm (B) | 2x 5cm FL | folded | sterile
SoFilm 95x65 (30 pouches in a box)305007GBZSME 95cm (A) x 65cm (B) | 2x 5cm FL | folded | sterile

Custom dimensions and versions are available on request.

Primary packaging containing the product
SoFilm is packed in a medical grade sterile barrier pouch to prevent recontamination of the product after sterilization. It provides an effective microbial barrier The pouch maintains sterility during storage and transport.

Secondary packaging (inner box)
10 pouches are packed in a carton inner box used to facilitate proper storage and internal transport to the user.

Transport packaging (outer box)
Either 3 or 6 inner boxes are packed in a carton outer box for external transporting of sterile goods in their primary and secondary packaging.


Somed

Eurotape B.V.
Oostergracht 2 / NL-3763 LZ Soest
The Netherlands