diagnostic FTRD Set

Basic Information

• Brand Name: diagnostic FTRD Set
• Primary DI: 04260206311072
• Version / Model: 13
• Catalog Number: 200.76
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-02
• Public Version: 6
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 10b2fe85-ce4b-4667-8cca-9e71737e1388

Device Description

The diagnostic FTRD 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 • enables a thorough pathological examination of e.g. motility disorders (e.g. Morbus Hirschsprung) • 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 three instruments: diagnostic FTRD (application cap with preloaded clip and 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)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	876.1500	2
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	876.4300	2
FDI	Snare, Flexible	Gastroenterology, Urology	876.4300	2
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61455	Endoscopic electrosurgical full-thickness tissue biopsy/resection set	A collection of sterile devices, which includes an implantable haemostatic ligation clip, intended to be used to obtain a full-thickness tissue biopsy and/or therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during an endoscopic procedure. It typically consists of a marking electrode and tissue grasper inserted through the endoscope and a cap with integrated electrosurgical snare that is placed on the distal end of the endoscope; a metallic clip is mounted on the cap. The pincer-like grasper pulls tissue into the cap before deploying the implanted, haemostatic ligation clip, followed by resection of the tissue pouch with the snare. This is a single-use device.	Yes	Active
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260206311072	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			working length 220 cm
Device Size Text, specify			working channel diameter 2.8 mm
Device Size Text, specify			for endoscopes diameter 10.5 - 12 mm

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius