Address:Friedrich-Miescher-Strasse 9,Tuebingen Baden-Wurttemberg,DE
Device Description : FTRD application cap for verification of possible application of the colonic FTR FTRD application cap for verification of possible application of the colonic FTRD Set (accessability and ability to pull lesion into cap)
Device Class : 1
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Fistula Brush can be used for probing of the fistula tract and for debrideme The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract
Device Class :
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic procedures such as polypectomy, endoscopic mucosa resection (EMR) or similar techniques • specific design - attached teeth to the distal part of the loop - reduces slipping of the snare upon closure • excellent maneuverability and repositioning properties • monopolar high-frequency instrument
Device Class : 2
Duns Number: 344007369
Premarket Exempt : No
Prescription Use : Yes
Device Description : The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full- The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full-thickness (or deep wall resection, especially in the stomach) resection via flexible endoscopy in the stomach and duodenum • technology is based on the well-established OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • the transection of the tissue happens only after the tissue has been closed completely • bowel lumen and abdominal cavity won't get into contact • It consists of the following five instruments, all single-use:• gastroduodenal FTRD (application cap with preloaded clip (special design for use in duodenum), integrated HF snare, endoscope sleeve, hand wheel and thread retriever • for colonoscopes)• FTRD Marking Probe (HF coagulation probe marking of the target lesion in preparation of FTRD use for detection and complete resection of the right tissue)• FTRD Grasper (specially designed grasping forceps proper grip on the target tissue precise retrieval of the sample into the application cap of the FTRD)• Insertion balloon (used to facilitate the insertion of the gastroduodenal FTRD through the mouth in the upper GI tract consists of a balloon, radiopaque markers, a catheter, a three-way handle and a yellow marker)• Guide wire (provided as insertion aid for the gastroduodenal FTRD to facilitate the insertion of the device into the upper GI-tract used in conjunction with an insertion balloon)
Device Class : 2
Duns Number: 344007369
Premarket Exempt : No
Prescription Use : Yes
Device Description : The FTRD Grasper is a specially designed grasping forceps for flexible endoscopy The FTRD Grasper is a specially designed grasping forceps for flexible endoscopy • grasping and manipulation of tissue and foreign bodies in the gastrointestinal tract, e.g. during intervention with the FTRD • proper grip and precise retrieval
Device Class : 1
Duns Number: 344007369
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • sa The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap)
Device Class : 1
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 • 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 • 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 • 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 • 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