Home GUDID 00821925035416 UroPass
Primary DI 00821925035416
Brand UroPass
Company Gyrus ACMI, LLC
Model 61246BX
Device description UroPass Ureteral Access Sheath 12/14 Fr (4/4.7 mm) x 46 cm (5/PK)
Published 2016-10-03
Public version status Update
Distribution status 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 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 00821925035256 Package GS1 5 In Commercial Distribution 00821925035416 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 00821925035256 00821925035256 821925035256 0821925035256 00821925035416 00821925035416 821925035416 0821925035416
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 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 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 00821925035430 UroPass Gyrus ACMI, LLC KNY 2016-10-03