AccessGUDID - DEVICE: colonic FTRD Set (04260206311010)

GUDID

Device Identifier (DI) Information

Brand Name: colonic FTRD Set
Version or Model: 14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.70
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206311010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use
Previous DI: 04260206310556

Device Description: The colonic 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 • 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: colonic 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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a 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 requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.	Active	false
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PKL	Hemostatic Metal Clip For The Gi Tract
FDI	Snare, Flexible
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 15 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: for endoscopes diameter 11.5-13.2 mm
Device Size Text, specify: working channel diameter 2.8 mm
Device Size Text, specify: working length 220 cm

Device Record Status

Public Device Record Key: bae97a45-e9d3-4aac-abd8-b8c157bafb0a
Public Version Date: August 07, 2024
Public Version Number: 7
DI Record Publish Date: May 28, 2018