Home GUDID 04260206311096
stentfix OTSC System Set
Primary DI 04260206311096
Brand stentfix OTSC System Set
Company Ovesco Endoscopy AG
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 2019-11-05
Public version status Update
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 04260206311096 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311096 04260206311096 4260206311096
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, and/or for treating mucosal/submucosal defects. 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 344007369 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 00850083048006 SimpleSnip ENVISION ENDOSCOPY, INC. OCZ 2026-07-17 00850083048068 SimpleSnip ENVISION ENDOSCOPY, INC. OCZ 2026-07-17 06959664913482 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915387 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915394 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915400 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915417 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915424 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915431 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915448 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915455 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915462 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915479 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915493 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915509 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915516 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915523 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915530 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915547 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915554 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915561 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915578 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915592 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915615 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915622 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915639 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915646 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915653 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915660 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915677 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16