FDA.reportPublic FDA data

ONYX 34

Primary DI
00847536006188
Brand
ONYX 34
Company
Micro Therapeutics, Inc.
Model
105-7100-080
Device description
105-7100-080 ONYX 34 KIT AVM US
Published
2015-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MFEAgent, injectable, embolic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFEAgent, Injectable, EmbolicUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030004000ONYX LIQUID EMBOLIC SYSTEMEv3 Neurovascular2005-07-21MFE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536006188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536006188008475360061888475360061880847536006188

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization plugA sterile, non-bioabsorbable, material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature19 Degrees Celsius24 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
826110710
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536036338PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-102023-12-31
00847536036390PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-252023-12-31
00847536036499PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-350-102023-12-31
00763000495626Axium™ Prime Detachable Coil SystemFC-9-20-3D2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemFC-9-30-3D2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemFC-10-30-3D2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemFC-10-40-3D2023-08-07
00763000488000Axium™ Detachable Coil SystemQC-2.5-2-HELIX2022-10-28
00763000488024Axium™ Detachable Coil SystemQC-2.5-6-HELIX2022-10-28
00763000488031Axium™ Detachable Coil SystemQC-2.5-8-HELIX2022-10-28
00763000488147Axium™ Detachable Coil SystemQC-7-30-HELIX2022-10-28
00763000488154Axium™ Detachable Coil SystemQC-8-20-HELIX2022-10-28
00763000488178Axium™ Detachable Coil SystemQC-9-20-HELIX2022-10-28
00763000488208Axium™ Detachable Coil SystemQC-10-30-HELIX2022-10-28
00763000488215Axium™ Detachable Coil SystemQC-12-30-HELIX2022-10-28
00763000488222Axium™ Detachable Coil SystemQC-12-40-HELIX2022-10-28
00763000488246Axium™ Detachable Coil SystemQC-14-40-HELIX2022-10-28
00763000488253Axium™ Detachable Coil SystemQC-16-30-HELIX2022-10-28
00763000488277Axium™ Detachable Coil SystemQC-18-40-HELIX2022-10-28
00763000488284Axium™ Detachable Coil SystemQC-20-40-HELIX2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150045549OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-06-01
00763000925338OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-01-02
00763000446741ApolloMicro Therapeutics, Inc.MFE2022-11-13
00763000446758ApolloMicro Therapeutics, Inc.MFE2022-11-13
00847536006010ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00847536006041ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00836462002463Apollo OnyxMicro Therapeutics, Inc.MFE2015-06-08
00836462002487Apollo OnyxMicro Therapeutics, Inc.MFE2015-06-08
00847536006171ONYX 18Micro Therapeutics, Inc.MFE2015-04-17
00836462005044Onyx 18Micro Therapeutics, Inc.MFE2014-09-22
00836462005051Onyx 34Micro Therapeutics, Inc.MFE2014-09-22