Home GUDID 14251244500594 Biotronik Fortress Introducer Sheath System
Primary DI 14251244500594
Brand Biotronik Fortress Introducer Sheath System
Company Contract Medical International GmbH
Model 65 cm, 6F Straight
Catalog number 444482
Device description Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Published 2018-11-30
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 14251244500594 Package GS1 5 In Commercial Distribution 04251244500597 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14251244500594 14251244500594 04251244500597 04251244500597 4251244500597
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, 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 65 Centimeter Lumen/Inner Diameter 2.2 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep dry Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 330926895 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 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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