Home GUDID 10851616002028 SteriGear
Primary DI 10851616002028
Brand SteriGear
Company Sterigear, LLC
Model REA4001-01
Device description Fig Leaf Lite 10273
Published 2020-11-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name FCN Urinary drainage collection kit, for indwelling catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851616002028 Package GS1 30 In Commercial Distribution 00851616002021 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 10851616002028 10851616002028 00851616002021 00851616002021 851616002021 0851616002021
GMDN Terms# Term, Definition table Term Definition Non-wearable adult urine collection bag, open-ended A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 809509297 Device count 1 DM exempt true Premarket exempt true 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 true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850063139403 Neil Medical Group Neil Medical Group FCN 2025-12-08 00850063139410 Neil Medical Group Neil Medical Group FCN 2025-12-08 00850063139427 Neil Medical Group Neil Medical Group FCN 2025-12-08 10192253051629 Dover Cardinal Health 200, LLC FCN 2025-11-07 00661392002388 LSL HEALTHCARE LSL Industries, LLC FCN 2025-10-30 00661392025646 LSL HEALTHCARE LSL Industries, LLC FCN 2025-10-30 10840330701751 ProCure Twin Med, LLC FCN 2025-05-31 10840330701768 ProCure Twin Med, LLC FCN 2025-05-31 10840330701775 ProCure Twin Med, LLC FCN 2025-05-31 10840330701782 ProCure Twin Med, LLC FCN 2025-05-31 30840330701755 ProCure Twin Med, LLC FCN 2025-05-31 30840330701762 ProCure Twin Med, LLC FCN 2025-05-31 30840330701779 ProCure Twin Med, LLC FCN 2025-05-31 30840330701786 ProCure Twin Med, LLC FCN 2025-05-31 00850058254791 TruCath HR PHARMACEUTICALS INC. FCN 2025-01-16 10192253027686 Dover Cardinal Health 200, LLC FCN 2024-10-14 50192253027684 Dover Cardinal Health 200, LLC FCN 2024-10-14 10192253065480 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065497 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065619 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065626 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065488 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065495 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065617 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065624 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253051612 Dover Cardinal Health 200, LLC FCN 2024-08-08 50192253051610 Dover Cardinal Health 200, LLC FCN 2024-08-08 10850053289085 SURGYCO Surgyco LLC FCN 2023-12-15 10850053289092 SURGYCO Surgyco LLC FCN 2023-12-15 10850053289108 SURGYCO Surgyco LLC FCN 2023-12-15
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