FTRD System Set

FDA UDI

Class II (US FDA UDI)

by Ovesco Endoscopy AG

Identity

Trade Name: FTRD System Set FDA UDI
Generic Name: Endoscopic electrosurgical full-thickness tissue biopsy/resection set FDA UDI
Device Name: The FTRD System Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following instruments: FTRD System (application cap with preloaded clip and integrated HF snare) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD System 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 System) FDA UDI
Model / Reference: 14 FDA UDI
Description: The FTRD System Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following instruments: FTRD System (application cap with preloaded clip and integrated HF snare) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD System 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 System) FDA UDI

Identifiers

Catalog Number: 200.70 FDA UDI
Primary DI / UDI-DI: 04260206310556 FDA UDI
FDA Product Code: OCZ FDA UDI
KNS FDA UDI
FDI FDA UDI
PKL FDA UDI
GMDN Term: Endoscopic electrosurgical full-thickness tissue biopsy/resection set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
876.4300 FDA UDI
876.4400 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

FTRD System Set by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ovesco Endoscopy AG

Sources (1)

FDA UDI a61e9cc9-16a5-41ab-a247-65fd17e7823a 37 fields · synced Jun 1, 2026