Home GUDID 05391525785127 Sublime™ Radial Access Guide Sheath
Primary DI 05391525785127
Brand Sublime™ Radial Access Guide Sheath
Company CREAGH MEDICAL LIMITED
Model SRA-GS35-5F120
Published 2020-12-07
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 DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391525785127 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391525785127 05391525785127 5391525785127
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). 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 Length 0
Regulatory Flags# DUNS number 985021909 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05391525785110 Sublime™ Radial Access Guide Sheath SRA-GS18-5F120 2020-12-07 05391525785134 Sublime™ Radial Access Guide Sheath SRA-GS18-5F150 2020-12-07 05391525785141 Sublime™ Radial Access Guide Sheath SRA-GS35-5F150 2020-12-07 05391525785158 Sublime™ Radial Access Guide Sheath SRA-GS18-6F120 2020-12-07 05391525785165 Sublime™ Radial Access Guide Sheath SRA-GS35-6F120 2020-12-07 05391525785172 Sublime™ Radial Access Guide Sheath SRA-GS18-6F150 2020-12-07 05391525785189 Sublime™ Radial Access Guide Sheath SRA-GS35-6F150 2020-12-07 05391525787480 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-50-220 2025-03-14 05391525787497 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-60-220 2025-03-14 05391525787503 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-70-220 2025-03-14 05391525785912 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20020 2021-10-20 05391525785929 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20040 2021-10-20 05391525785936 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20060 2021-10-20 05391525785943 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20080 2021-10-20 05391525785950 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20100 2021-10-20 05391525785967 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20120 2021-10-20 05391525785974 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20150 2021-10-20 05391525785981 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20220 2021-10-20 05391525785998 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-25020 2021-10-20 05391525786001 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-25040 2021-10-20
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