Home GUDID 20607915125947 ACUCISE® PROCEDURAL PACK STARTER PACK
Primary DI 20607915125947
Brand ACUCISE® PROCEDURAL PACK STARTER PACK
Company APPLIED MEDICAL RESOURCES CORPORATION
Model BK001
Device description Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB1201, URO TAMPONADE BALLOON CATHB3304, STENT, C-FLEX 7/10F x 24 CMB3301, STENT, C-FLEX, 7/10F X 26CMB3302, STENT, C-FLEX, 7/10F X 28CMB3303, STENT, C-FLEX, 7/10F X 30CMB7016, FORTE AxP SET 12/14/18F 35CM 6/BX
Published 2015-10-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name DXT Injector And Syringe, Angiographic EYB Catheter, Ureteral, Gastro-Urology EZB Stylet For Catheter, Gastro-Urology FAD Stent, Ureteral FED Endoscopic Access Overtube, Gastroenterology-Urology KNY Accessories, Catheter, G-U
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXT Injector And Syringe, Angiographic Cardiovascular 2 EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology 2 EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology 1 FAD Stent, Ureteral Gastroenterology, Urology 2 FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology 2 KNY Accessories, Catheter, G-U Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20607915125947 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20607915125947 20607915125947
GMDN Terms# Term, Definition table Term Definition Ureteral stent-placement set A collection of devices used to facilitate the implantation of a ureteral stent, via the natural orifice or percutaneously through a tortuous ureter, in order to maintain ureteral patency. The devices are typically made of high-grade stainless steel and/or a polymer [e.g., polyvinyl chloride (PVC)] and typically include a guidewire, a dilator, a positioner, an inserter, a placement catheter, an introduction sheath, and a release sleeve. Some of the devices may be radiopaque, and may have Luer connectors at the proximal end to allow for the injection of a contrast medium. This is a single-use device.
Regulatory Flags# DUNS number 187129135 Device count 1 Kit true Lot or batch 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 00190776434137 Millennium Avalign Technologies, Inc. EZB 2026-10-09 00860013645120 Prodeon Urethral Sheath System Prodeon Medical, Inc. FED 2026-10-07 00191506062514 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062521 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062538 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062545 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062552 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062569 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062576 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062583 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 00191506062590 Navigator™ BOSTON SCIENTIFIC CORPORATION FED 2026-09-25 06936534343020 Disposable Ureteral Stents Zhejiang Chuangxiang Medical Technology Co., LTD. FAD 2026-09-22 06942804744602 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744619 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744626 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744633 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744640 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744657 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744664 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744671 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744688 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744695 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744701 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744718 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744725 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744732 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744749 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744756 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744763 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22 06942804744770 Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., LTD. FED 2026-09-22