Home GUDID 00821925035201 UroPass Ureteral Access Sheath
Primary DI 00821925035201
Brand UroPass Ureteral Access Sheath
Company Gyrus Acmi, Inc.
Model 61138BX
Published 2016-10-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KNY ACCESSORIES, CATHETER, G-U
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KNY Accessories, Catheter, G-U Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925035201 Package GS1 5 In Commercial Distribution 00821925035362 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00821925035201 00821925035201 821925035201 0821925035201 00821925035362 00821925035362 821925035362 0821925035362
GMDN Terms# Term, Definition table Term Definition Ureteral catheter A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10192253027648 Dover Cardinal Health 200, LLC KNY 2024-07-10 50192253032336 Dover Cardinal Health 200, LLC KNY 2024-07-10 50192253027646 Dover Cardinal Health 200, LLC KNY 2024-07-10 10192253032338 Dover Cardinal Health 200, LLC KNY 2024-07-10 03700512966197 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm Promepla KNY 2017-11-09 03700512966203 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm Promepla KNY 2017-11-09 03700512966210 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm Promepla KNY 2017-11-09 03700512966227 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm Promepla KNY 2017-11-09 03700512986195 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm Promepla KNY 2017-11-09 03700512986201 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm Promepla KNY 2017-11-09 03700512986218 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm Promepla KNY 2017-11-09 03700512986225 Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm Promepla KNY 2017-11-09 00821925036345 VARI-PASS Gyrus ACMI, LLC KNY 2017-05-11 00821925027589 VARI-PASS 10/12 Fr (3.3/4mm) x 54CM Gyrus Acmi, Inc. KNY 2017-05-11 10680651445787 Halyard Avanos Medical, Inc. KNY 2017-05-10 00821925035393 UroPass Gyrus ACMI, LLC KNY 2016-10-12 00821925035409 UroPass Gyrus ACMI, LLC KNY 2016-10-12 00821925035423 UroPass Gyrus ACMI, LLC KNY 2016-10-12 00821925005976 UroPass Ureteral Access Sheath Gyrus Acmi, Inc. KNY 2016-10-12 00821925005983 UroPass Ureteral Access Sheath Gyrus Acmi, Inc. KNY 2016-10-12 00821925005990 UroPass Ureteral Access Sheath Gyrus Acmi, Inc. KNY 2016-10-12 00821925035317 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035324 GYRUS ACMI, INC Gyrus ACMI, LLC KNY 2016-10-03 00821925035331 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035348 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035355 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035362 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035379 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035386 UroPass Gyrus ACMI, LLC KNY 2016-10-03 00821925035416 UroPass Gyrus ACMI, LLC KNY 2016-10-03