Drop control device
DESIGNATION
Drop control device
DESCRIPTION
Device consisting of:
- catheter with luer connection complete with bevelled needle exclusively for application of GLUBRAN 2 surgical glue;
- 2.5 ml luer syringe complete with bevelled needle
METHOD OF USE
Single use, exclusively for the application of GLUBRAN 2 surgical glue during surgical procedures. In sterile conditions, remove the syringe with needle from the packaging and aspirate GLUBRAN 2 surgical glue from the vial as prescribed. Remove the needle used to aspirate the glue. Connect the drop control device to the syringe and press the piston several times until the glue begins to appear at the tip of the needle.
INTENDED USE
For open surgery, controlled application of Glubran 2 surgical glue is necessary in case of haemostasis, adhesion, sealing or suture reinforcement is required. Video
MATERIALS
Medical Grade PVC, polypropylene and polystyrene
CODE
G2-DCD-210-8T
STERILIZATION
Gamma rays
SHELF LIFE
5 years
PACKAGING
Single sterile peel pouch
STORAGE
Standard – Keep product in its original packaging in a clean, cool, dry place at temperatures below 30°C.
COMPLIANCE DIRECTIVE
MMD/93/42/EEC
QUALITY CONTROL
During production and on the biocompatibility of the materials
CLASS
IIa
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Quality Certifications

GEM srl obtained the following Quality Certifications released by TUV Product Service in 2006:
- EN ISO 13485:2003
- UNI EN ISO 9001:2000
- TUV America Inc ISO 13485:2003




