FDA.reportPublic FDA data

Target

Primary DI
04546540711670
Brand
Target
Company
Stryker Corporation
Model
M0036154080
Catalog number
615408
Device description
3D Detachable Coil
Published
2015-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123377000TARGET DETACHABLE COILStryker Neurovascular2012-11-30HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540711670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540711670045465407116704546540711670

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA sterile, 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
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, dark place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)916-3876NVCustomerService@stryker.com

Regulatory Flags#

DUNS number
042405446
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488734Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00847536032828AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.KRD2019-06-29