Home GUDID 04260206311690 OTSC System Set
Primary DI 04260206311690
Brand OTSC System Set
Company Ovesco Endoscopy Usa, Inc.
Model 12/6 t - 220
Catalog number 100.31
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 04260206311690 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311690 04260206311690 4260206311690
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 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