Home GUDID 10857798005093 Nitinol Enhanced Device
Primary DI 10857798005093
Brand Nitinol Enhanced Device
Company Embolization Inc.
Model N3F-3400
Catalog number N3F-3400
Device description Peripheral vascular embolization device Framing 3-4mm Vessel Diameter
Published 2026-02-12
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KRD Device, Vascular, For Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10857798005093 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10857798005093 10857798005093
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization coil A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight, Keep dry Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -18 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 144855401 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10857798005109 Nitinol Enhanced Device N3F-4500 N3F-4500 2026-02-12 10857798005123 Nitinol Enhanced Device N3P-0035 N3P-0035 2026-02-12 10857798005130 Nitinol Enhanced Device N3F-2300 N3F-2300 2026-02-12 10857798005147 Nitinol Enhanced Device N3P-0023 N3P-0023 2026-02-12
Other Devices Sharing Product Codes# 
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