Home GUDID 04251244500016 Biotronik Fortress Introducer Sheath System
Primary DI 04251244500016
Brand Biotronik Fortress Introducer Sheath System
Company Contract Medical International GmbH
Model 45 cm, 4F Straight
Catalog number 358814
Device description Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
Published 2016-06-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 14251244500013 Package GS1 5 In Commercial Distribution 04251244500016 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14251244500013 14251244500013 04251244500016 04251244500016 4251244500016
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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 45 Centimeter Lumen/Inner Diameter 1.62 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 Keep away from direct sunlight Special Storage Condition, Specify 0 0 Keep dry
Regulatory Flags# DUNS number 330926895 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04251244501983 Catapult Guide Sheath 4F, 45cm, straight, hydrophilic coated US-34045-F-ST-H 2023-09-01 04251244501990 Catapult Guide Sheath 4F, 60cm, straight, hydrophilic coated US-34060-F-ST-H 2023-09-01 04251244502003 Catapult Guide Sheath 4F, 90cm, straight, hydrophilic coated US-34090-F-ST-H 2023-09-01 04251244502010 Catapult Guide Sheath 5F, 15cm, straight, hydrophilic coated US-35015-F-ST-H 2023-09-01 04251244502027 Catapult Guide Sheath 5F, 45cm, straight, hydrophilic coated US-35045-F-ST-H 2023-09-01 04251244502034 Catapult Guide Sheath 5F, 45cm, Multipurpose, hydrophilic coated US-35045-F-MP-H 2023-09-01 04251244502041 Catapult Guide Sheath 5F, 45cm, RDC, hydrophilic coated US-35045-F-RDC-H 2023-09-01 04251244502058 Catapult Guide Sheath 5F, 45cm, Hockey stick, hydrophilic coated US-35045-F-HS-H 2023-09-01 04251244502065 Catapult Guide Sheath 5F, 60cm, straight, hydrophilic coated US-35060-F-ST-H 2023-09-01 04251244502072 Catapult Guide Sheath 5F, 90cm, straight, hydrophilic coated US-35090-F-ST-H 2023-09-01 04251244502089 Catapult Guide Sheath 6F, 15cm, straight, hydrophilic coated US-36015-F-ST-H 2023-09-01 04251244502096 Catapult Guide Sheath 6F, 45cm, straight, hydrophilic coated US-36045-F-ST-H 2023-09-01 04251244502102 Catapult Guide Sheath 6F, 45cm, Multipurpose, hydrophilic coated US-36045-F-MP-H 2023-09-01 04251244502119 Catapult Guide Sheath 6F, 45cm, LIMA, hydrophilic coated US-36045-F-LIMA-H 2023-09-01 04251244502126 Catapult Guide Sheath 6F, 45cm, RDC, hydrophilic coated US-36045-F-RDC-H 2023-09-01 04251244502133 Catapult Guide Sheath 6F, 45cm, Hockey stick, hydrophilic coated US-36045-F-HS-H 2023-09-01 04251244502140 Catapult Guide Sheath 6F, 60cm, straight, hydrophilic coated US-36060-F-ST-H 2023-09-01 04251244502157 Catapult Guide Sheath 6F, 90cm, straight, hydrophilic coated US-36090-F-ST-H 2023-09-01 04251244502164 Catapult Guide Sheath 6F, 90cm, Multipurpose, hydrophilic coated US-36090-F-MP-H 2023-09-01 04251244502171 Catapult Guide Sheath 6F, 90cm, RDC, hydrophilic coated US-36090-F-RDC-H 2023-09-01
Other Devices Sharing Product Codes# 
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