FDA.reportPublic FDA data

TARGET

Primary DI
04546540675958
Brand
TARGET
Company
Stryker Corporation
Model
M0035425100
Catalog number
542510
Device description
360 Ultra 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540675958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540675958045465406759584546540675958

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA sterile, non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; 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 a cool, dry 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
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578584Target TetraStryker CorporationHCG2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578614Target TetraStryker CorporationHCG2022-12-19
07613327578621Target TetraStryker CorporationHCG2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578645Target TetraStryker CorporationHCG2022-12-19
07613327578652Target TetraStryker CorporationHCG2022-12-19
07613327578669Target TetraStryker CorporationHCG2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578713Target TetraStryker CorporationHCG2022-12-19
07613327578720Target TetraStryker CorporationHCG2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
07613327580105Target TetraStryker CorporationHCG2022-12-19
07613327466379TARGETStryker CorporationHCG2019-09-05
07613327466386TARGETStryker CorporationKRD2019-09-05
07613327466393TARGETStryker CorporationHCG2019-09-05
07613327466409TARGETStryker CorporationHCG2019-09-05
07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
07613327128307TARGETStryker CorporationHCG2017-06-26
07613327128345TARGETStryker CorporationHCG2017-06-26
07613327128352TARGETStryker CorporationKRD2017-06-26
07613327128369TARGETStryker CorporationKRD2017-06-26