Ftrd System Set
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…
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)
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Record
| Listed by | Ovesco Endoscopy AG, Germany |
|---|---|
| FDA product code | OCZ |
| Device type | Endoscopic Grasping/Cutting Instrument, Non-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-07-31 |
| Record revised | 2020-02-06 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2019-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14 | working length 220 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Stryker GmbH | 176 |
| Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 53 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Karl Storz GmbH & Co. KG | 42 |
| Hobbs Medical Polypectomy Snare | Hobbs Medical, Inc. | 27 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Richard Wolf Gmbh | 24 |
| Hysafe | Richard Wolf Gmbh | 22 |
| Grasping Forceps | Olympus Medical Systems Corp. | 17 |
| EndoTBasket | Endo-Therapeutics, Inc. | 13 |
| Halyard | Avanos Medical, Inc. | 11 |
| Hobbs Helical Retrieval Basket | Hobbs Medical, Inc. | 8 |
| Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | 6 |
| Foreign Body Grasping Forceps | Avanos Medical, Inc. | 6 |
Showing 12 of 31. All products under Endoscopic Grasping/Cutting Instrument, Non-Powered
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.