Data sheet_Biopad (17-03-2014)
Pagina 1 di 2
Technical data sheet
Commercial name
Biopad O.R. 5 x 5 cm
Commercial Code
MB001000
Description
Biopad is constituted by native heterologous type I horse collagen, lyophilized and
sterile, under form of spongy pad (tri-dimensional scaffold), easily adaptable to the
areas of application.
The dimensions of the membrane in the dry state (lyophilized) are 50 x 50 x 5 mm
Membrane is white, porous and rough on both sides.
Intended use
For use as adjuvant in the repair processes in orthopedic surgery.
Its absorbent capacity, measured with saline solution, is about 30 times its weight; this
propriety ensures a high capacity of absorption of liquid and possible transport of
cellular material within the construct
The membrane, if loaded with autologous cells concentrated from bone marrow, is
advised for the treatment of chondral and osteo-chondral defects.
Biopad membrane can be easily shaped by means of a sterile scissors and adapted to
the size of the defect and surface to be treated.
The particular three-dimensional structure of BIOPAD membrane allows the
penetration of the cells in its structure.
To ensure the optimum absorption of the cells in the three-dimensional plot of the
membrane, it is necessary to wait 4/5 minutes after application of the concentrated cell
on the surface.
Manufacturer
EURORESEARCH SRL
Via Larga, 2 – 20122 Milano – Italy
0373
CND Code
M04041001_medication of pure animal origin collagen
GMDN Code
45023 - Dressing, occlusive, collagen_ a collagen protein matrix used to provide
an occlusive/semi-occlusive cover for a wound, primarily to maintain a clean and
moist environment for healing. the device is used for various types of partial- and
full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions,
burns, or surgical wounds. it may combine collagen with supplemental dressing
materials (e.g., alginate); it is supplied in various forms. this is a single-use device.
NOVAGENIT S.r.l.
Sede legale: Viale Trento, 115/117 – 38017 Mezzolombardo (TN) – Tel: +39-0461-600002 Fax: +39-0461-606987
Ufficio Commerciale: Via Ciro Menotti, 11/D - 20129 Milano (MI) - Tel.: +39-02-615 437 404 – Fax: +39-02-615 437 417
Reg. Imprese Trento P.IVA/C.F. 01949700221- R.E.A. TN 189838 - Capitale Sociale 1.000.000,00 € i.v.
B
I
O
P
A
D
Data sheet_Biopad (17-03-2014)
Pagina 2 di 2
Type of Product
Medical Device – according to Directive 93/42 EEC and following amendments
including Directive 2007/47 EEC
Medical device Repertory N°
105352/R
Class of the medical device
Class III – according to the rule 17 of the Annex IX of the Directive 93/42/EEC
Sterilization
Gamma irradiation (25KGy). Do not re-sterilize.
Conformity to standards
CE Marking - Verification of conformity, CE marking (Annex III) coupled with the
procedure of the System of Quality Assurance for the production (Annex V), according
to Directives 93/42/EEC and 2007/47/EEC. Biopad in addition is conform to Directive
2003/32/ EEC, UNI EN ISO 9001, ICH Q9 and ISO 13485.
Biocompatibility studies conducted in accordance with UNI EN ISO 10993 Part 3-5-10
have shown that the Biopad is not cytotoxic, irritating, sensitizing, mutagenic.
Moreover, the LAL test performed according to USP 27 shows that the Biopad is not
pyrogenic
CE Certificate
Biopad is CE marked according to Art.11 and according to Annexes III and V of Directive
93/42/EEC
CE Certificate Nr CTP-0804-13 issued by Istituto Superiore di Sanità on 05.12.2013,
Notified Body n° 0373
Storage conditions
Keep the product in a dry place, away from heat sources.
The membrane suitably stored and in its integral packaging has a shelf life of 5 years.
Do not use after the expiry date
Packaging
Box containing 1 sterile pad in double blister. This type of packaging allows the use of the
pad in operating room.
Do not use if the packaging is damaged.
Materials used
100% Collagen Type 1, freeze-dried, anallergic.
The equine material used, being a connective tissue (tendon), is classified by EMEA as
"Class IV - No detectable infectivity"
The material comes from a qualified supplier, licensed within the EC, and from country
recognized as being free from BSE / TSE and is supported by all the relevant
documentation in accordance with applicable regulations
Disposal
After opening the blister, if only part of the pad is used, do not re-use the
remaining portions for subsequent applications
The user must follow the legal regulations regarding disposal of hospital waste
potentially infectious.
NOVAGENIT S.r.l.
Sede legale: Viale Trento, 115/117 – 38017 Mezzolombardo (TN) – Tel: +39-0461-600002 Fax: +39-0461-606987
Ufficio Commerciale: Via Ciro Menotti, 11/D - 20129 Milano (MI) - Tel.: +39-02-615 437 404 – Fax: +39-02-615 437 417
Reg. Imprese Trento P.IVA/C.F. 01949700221- R.E.A. TN 189838 - Capitale Sociale 1.000.000,00 € i.v.