FDA.reportPublic FDA data

TARGET XL

Primary DI
07613327128321
Brand
TARGET XL
Company
Stryker Corporation
Model
M0036122030
Catalog number
612203
Device description
360 SOFT Detachable Coil
Published
2015-11-06
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
07613327128321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327128321076133271283217613327128321

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
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06