Home GUDID 00814548017358 Smart Coil
Primary DI 00814548017358
Brand Smart Coil
Company PENUMBRA, INC.
Model 400SMTHXSFT4H08
Device description 400SMTHXSFT4H08
Published 2016-07-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Sterile true
Single use true Product Codes# Code, Name table Code Name HCG DEVICE, NEUROVASCULAR EMBOLIZATION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCG Device, Neurovascular Embolization Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814548017358 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814548017358 00814548017358 814548017358 0814548017358
GMDN Terms# Term, Definition table Term Definition Vascular microcatheter A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Regulatory Flags# DUNS number 191077671 Device count 1 Lot or batch true Serial number true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613327578584 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578614 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578621 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578645 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578652 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578669 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578713 Target Tetra Stryker Corporation HCG 2022-12-19 07613327578720 Target Tetra Stryker Corporation HCG 2022-12-19 07613327580105 Target Tetra Stryker Corporation HCG 2022-12-19 07613327466379 TARGET Stryker Corporation HCG 2019-09-05 07613327466393 TARGET Stryker Corporation HCG 2019-09-05 07613327466409 TARGET Stryker Corporation HCG 2019-09-05 07613327128307 TARGET Stryker Corporation HCG 2017-06-26 07613327128345 TARGET Stryker Corporation HCG 2017-06-26 07613327128383 TARGET Stryker Corporation HCG 2017-06-26 00847536022812 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022836 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022867 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022881 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022904 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022911 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022928 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022935 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022966 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022973 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022980 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536022997 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536023000 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536023017 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04 00847536023024 AxiumTM Micro Therapeutics, Inc. HCG 2017-02-04