Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ฎ๐Ÿ‡ณ India

Menox

Meril Life Sciences Pvt. Ltd. ยท ๐Ÿ‡ฎ๐Ÿ‡ณ India
Devices (same UDI-DI)
1
Certificates
2
Countries
13
Notified Bodies
2

Basic Information

Primary DI
18904224927183
Basic UDI-DI Code
B-18904224927183
Reference
MNX20
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

Menoxโ„ข Liquid Embolic System (LES) is available in three (03) model variants: 1) Menox Liquid Embolic System (18 cSt viscosity) 2) Menox Liquid Embolic System (20 cSt viscosity) 3) Menox Liquid Embolic System (34 cSt viscosity) The Menox Liquid Embolic System consists of following components: - Menox 18/Menox 20/Menox 34 Liquid Embolic Material (LEM)(1.5 ml vial ) - Dimethyl sulfoxide (DMSO) (1.5 ml vial) - 1 ml DMSO compatible syringe (3 nos.) Menox Liquid Embolic System is intended for Presurgical Embolization of brain Arteriovenous Malformation (bAVMs). 1) Menox LES (18cSt ) and Menox LES (20 cSt) - Recommended when feeding pedicle injections will be conducted close to nidus of brain Arteriovenous Malformations (bAVM)TM 2) Menox LES (34 cSt) - Recommended for embolizing higher flow and larger fistulous components.Menox Liquid Embolic Material is non-adhesive liquid embolic agent comprised of EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy.Dimethyl sulfoxide (DMSO) act as a flushing agent. DMSO is injected to fill the dead space of micro catheter prior to injection of Menox. Injection of DMSO prevents the unintentional precipitation of Menox, which immediately begins when there is contact to water, saline solution or blood. A total of 03 DMSO compatible 1 ml syringes are provided to deliver Menox and DMSO. Two white colored piston syringes are used to deliver Menox and one blue colored piston syringe is used to deliver DMSO.Menox LEM is delivered by slow controlled injection through a micro catheter into the brain arteriovenous malformation under fluoroscopic control. DMSO compatible delivery micro catheter that is indicated for use in the neuro vasculature is used to access the embolization site.

CND Nomenclature Codes

Code Description
N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER

Certificates

Type Number
MDD Annex II Section 4 1783-MDD-065
MDD Annex II (excluding section 4) 1783-MDD-064

Available In Countries

๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

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