Home GUDID 04260206311652
OTSC System Set
Primary DI 04260206311652
Brand OTSC System Set
Company Ovesco Endoscopy Usa, Inc.
Model 12/6 gc
Catalog number 100.27
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 04260206311652 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311652 04260206311652 4260206311652
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 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 06959664915684 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16 06959664915691 NA Hangzhou AGS MedTech Co., Ltd. PKL 2026-07-16