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 06959664917299 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664917305 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664917312 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664917329 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664917336 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664919712 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664919729 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664919736 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664919743 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664919750 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920169 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920176 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920183 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920190 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920206 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920305 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920312 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920329 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920336 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920343 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920350 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920510 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920527 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920534 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920541 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920558 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920763 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920770 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920787 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07 06959664920794 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-08-07