Home GUDID 03600040995167 ReTrace
Primary DI 03600040995167
Brand ReTrace
Company Coloplast A/S
Model ACXL10
Catalog number ACXL10
Published 2024-11-20
Public version status New
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 FED endoscopic access overtube, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03600040995167 Package GS1 1 In Commercial Distribution 03600040995174 Package GS1 24 In Commercial Distribution 03600040995150 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03600040995167 03600040995167 3600040995167 03600040995174 03600040995174 3600040995174 03600040995150 03600040995150 3600040995150
GMDN Terms# Term, Definition table Term Definition Ureteral introduction sheath A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Regulatory Flags# DUNS number 305524696 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 06936345101536 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345101543 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104469 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104476 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104483 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104490 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104544 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104551 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104568 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104575 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06925816667213 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816667220 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816667237 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816657511 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657528 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657535 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657542 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657559 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657566 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657573 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657580 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657597 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657603 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657610 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657627 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657634 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657641 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657658 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657665 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657672 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26