Home GUDID 04260206311560 OTSC System Set
Primary DI 04260206311560
Brand OTSC System Set
Company Ovesco Endoscopy Usa, Inc.
Model 12/3 t
Catalog number 100.06
Device description The 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 acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
Published 2024-09-10
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 PKL Hemostatic Metal Clip For The Gi Tract
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260206311560 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311560 04260206311560 4260206311560
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