Home GUDID H787065076015 Embosafe
Primary DI H787065076015
Brand Embosafe
Company ANGIODYNAMICS, INC.
Model 06507601
Device description Valved Peelable Introducer Sheath
Published 2016-09-20
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 DQR CANNULA, CATHETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQR Cannula, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H787065076015 Package HIBCC 5 In Commercial Distribution H787065076010 Primary HIBCC 0
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 Catheter Gauge 14 French
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 27 Degrees Celsius
Regulatory Flags# DUNS number 079105071 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840479400167 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401034 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401058 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401072 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479400174 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401041 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401065 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 00840479401089 enableCV OptiSite™ Arterial Perfusion Cannula ENABLECV INC. DQR 2026-02-06 05415067042835 NA ST. JUDE MEDICAL, INC. DQR 2022-02-16 H787065068010 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065068020 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065068030 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065068040 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065068050 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072010 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072020 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072030 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072040 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072100 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072110 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072120 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065072130 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065076010 Embosafe ANGIODYNAMICS, INC. DQR 2016-09-20 H787065076020 Embosafe ANGIODYNAMICS, INC. DQR 2016-09-20 H787065076030 Embosafe ANGIODYNAMICS, INC. DQR 2016-09-20 H787065084020 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065084030 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065084040 Morpheus ANGIODYNAMICS, INC. DQR 2016-09-20 H787065086010 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20 H787065086020 Micro Access ANGIODYNAMICS, INC. DQR 2016-09-20
angiodynamics.com