Home GUDID 04260206311706 stentfix OTSC System Set
Primary DI 04260206311706
Brand stentfix OTSC System Set
Company Ovesco Endoscopy Usa, Inc.
Model stentfix
Catalog number 100.50
Device description The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant
Published 2024-09-13
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered PKL Hemostatic Metal Clip For The Gi Tract
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology 2 PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260206311706 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311706 04260206311706 4260206311706
GMDN Terms# Term, Definition table Term Definition Gastrointestinal endoscopic clip, long-term, non-bioabsorbable A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 969139760 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664900086 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900178 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900185 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900192 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900291 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900307 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900314 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900543 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900550 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900574 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900598 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900635 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900666 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900697 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900840 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900864 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900871 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900888 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900895 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900901 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664900918 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664901144 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664901151 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664902813 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664902820 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664902837 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664902851 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664969526 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664969533 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19 06959664969540 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-19