Address:Friedrich-Miescher-Strasse 9,Tuebingen Baden-Wurttemberg,DE
Device Description : The mini OTSC System extends the OTSC System by a smaller size • it can be use The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
Device Class : 2
Duns Number: 344007369
Premarket Exempt : No
Prescription Use : Yes
Device Description : The stentfix OTSC System Set consists of a clip preloaded onto an application ca The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant
Device Class : 2
Duns Number: 344007369
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that ca The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp large volume of tissue or foreign bodies • for use with standard flexible endoscopes • allows for the use of additional endoscopic instruments or a guide wire through the working channel of the endoscope • flexible shaft • includes an endoscope sleeve and appropriate adhesive tapes
Device Class : 1
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The LiftUp Kit contains the LiftUp injection solution (5 vials with 20 ml each) The LiftUp Kit contains the LiftUp injection solution (5 vials with 20 ml each) and injection accessories (10 syringes and 5 injection needles).
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The BougieCap is for dilation of strictures in the upper gastrointestinal tract The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Device Class : 2
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes