FDA.reportPublic FDA data

Neuroform Atlas

Primary DI
07613252656173
Brand
Neuroform Atlas
Company
Stryker Corporation
Model
M003SZAS40150
Catalog number
SZAS4015
Device description
WITHOUT TIP Stent System
Published
2018-01-12
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
NJEintracranial neurovascular stent
QCAIntracranial coil-assist stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf
QCAIntracranial Coil-Assist StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020002046

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020002046

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252656173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252656173076132526561737613252656173

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA sterile non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Millimeter
Outer Diameter4Millimeter

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
07613252254430VertaPlex04066220000406-622-0002016-09-23
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
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429117743StentMicrovention, Inc.QCA2023-04-26
00842429117750StentMicrovention, Inc.QCA2023-04-26
00842429117767StentMicrovention, Inc.QCA2023-04-26
00842429117774StentMicrovention, Inc.QCA2023-04-26
00842429117781StentMicrovention, Inc.QCA2023-04-26
00842429117798StentMicrovention, Inc.QCA2023-04-26
00842429117804StentMicrovention, Inc.QCA2023-04-26
00842429117811StentMicrovention, Inc.QCA2023-04-26
00842429117828StentMicrovention, Inc.QCA2023-04-26
00842429117835StentMicrovention, Inc.QCA2023-04-26
00842429117842StentMicrovention, Inc.QCA2023-04-26
00842429117859StentMicrovention, Inc.QCA2023-04-26
00842429117866StentMicrovention, Inc.QCA2023-04-26
00842429117873StentMicrovention, Inc.QCA2023-04-26
00842429117880StentMicrovention, Inc.QCA2023-04-26
00842429117897StentMicrovention, Inc.QCA2023-04-26
00842429117903StentMicrovention, Inc.QCA2023-04-26
00859030005253PulseRiderMedos International SàrlNJE2019-09-17
00859030005260PulseRider Aneurysm Neck Reconstruction Device Connection CableMedos International SàrlNJE2019-09-17
07613327382129Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382136Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382143Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382150Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382167Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382174Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382181Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382198Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382204Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382211Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382228Neuroform AtlasStryker CorporationQCA2019-06-20