Home GUDID 20607915128207 ACUCISE® PROCEDURAL PACK FEMALE PACK C
Primary DI 20607915128207
Brand ACUCISE® PROCEDURAL PACK FEMALE PACK C
Company APPLIED MEDICAL RESOURCES CORPORATION
Model BK025
Device description Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB3304, STENT, C-FLEX 7/10F x 24 CMB3301, STENT, C-FLEX, 7/10F X 26CMB7076, FORTE AxP SET 12/14/18F 28CM 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 FZP Clip, Implantable KNY Accessories, Catheter, G-U MDM Instrument, Manual, Surgical, General Use
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 FZP Clip, Implantable General, Plastic Surgery 2 KNY Accessories, Catheter, G-U Gastroenterology, Urology 2 MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20607915128207 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20607915128207 20607915128207
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# 
appliedmedical.com