Extension of shelf life Adcon® Gel to 30 months
Leader Biomedical’s Adcon® Gel – anti-adhesion gel – is reviewed, approved and extended by notified body DEKRA to 30 months (previously 18months).
The approval of the change will not impact the certification structure. Applicable NBOG device codes are MD0204, MDS7002, MDS700, and MDS7009. Compliance was reviewed against the following directives, standards, and guidances:
- MDD 93/42 EEC
- ISO EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices
“part 1: Requirements for materials, sterile barrier systems and packaging systems”
About Adcon® Gel:
Adcon® Gel is a biocompatible resorbable gel, composed of polyglycan ester combined with absorbable gelatine in a phosphate-buffered saline. Adcon® Gel is provided sterile in a syringe. Adcon® Gel has extensive clinical history with over 300,000 cases worldwide in more than 10 clinical studies since 1996 and provides a physical barrier to inter-tissue adhesions and inhibits fibroblast migration. This results in improved patient rehabilitation, reduced recurrent pain, and decreased number of re-operations as a result of such adhesions.