FDA.reportPublic FDA data

Onyx 34

Primary DI
00836462005051
Brand
Onyx 34
Company
Micro Therapeutics, Inc.
Model
105-7100-080
Device description
Liquid Embolic 105-7100-080 Onyx 34
Published
2014-09-22
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
P030004008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030004008ONYX LIQUID EMBOLIC SYSTEMEv3 Neurovascular2005-07-21MFE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462005051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462005051008364620050518364620050510836462005051

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
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT
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
00847536036277PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-275-102023-12-31
00847536036413PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-325-102023-12-31
00847536036475PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-325-252023-12-31
00763000495619Axium™ Prime Detachable Coil SystemFC-8-30-3D2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemFC-10-20-3D2023-08-07
00763000488673Axium™ Detachable Coil SystemQC-14-40-3D2022-10-28
00763000488703Axium™ Detachable Coil SystemQC-20-50-3D2022-10-28
00763000488734Axium™ Detachable Coil SystemNC-2-1-HELIX2022-10-28
00763000488949Axium™ Detachable Coil SystemPC-4-10-HELIX2022-10-28
00763000489182Axium™ Detachable Coil SystemPC-5-10-3D2022-10-28
00763000489250Axium™ Detachable Coil SystemPC-7-30-3D2022-10-28
00763000489281Axium™ Detachable Coil SystemPC-8-30-3D2022-10-28
00763000489328Axium™ Detachable Coil SystemPC-10-30-3D2022-10-28
00763000425272Solitaire ™ PlatinumSFR3-4-20-102021-03-12
00763000425333Solitaire ™ PlatinumSFR3-4-40-102021-03-12
00763000425395Solitaire ™ PlatinumSFR3-6-20-102021-03-12
00763000425456Solitaire ™ PlatinumSFR3-4-20-052021-03-12
00836462018273N/ANCS-2.75-52016-10-02
00763000270704Solitaire™ X-PACKXPACK3362019-11-08
00763000270766Solitaire™ X-PACKXPACK3422019-11-08

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
00847536006188ONYX 34Micro Therapeutics, Inc.MFE2015-04-17
00836462005044Onyx 18Micro Therapeutics, Inc.MFE2014-09-22