Home GUDID 00850053289095 SURGYCO
Primary DI 00850053289095
Brand SURGYCO
Company Surgyco LLC
Model ST001005
Device description Pre-Connected Foley Catheter Tray 16FR.
Published 2023-12-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 10850053289092 Primary GS1 0 00850053289095 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850053289092 10850053289092 00850053289095 00850053289095 850053289095 0850053289095
GMDN Terms# Term, Definition table Term Definition General-purpose syringe, single-use A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
Regulatory Flags# DUNS number 118768538 Device count 10 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 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