FDA.reportPublic FDA data

Neuroform Atlas

Primary DI
07613327382235
Brand
Neuroform Atlas
Company
Stryker Corporation
Model
M003UZAS30300
Catalog number
UZAS3030
Device description
WITHOUT TIP Stent System
Published
2019-06-20
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
QCAIntracranial coil-assist stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCAIntracranial Coil-Assist StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180031000Neuroform Atlas® Stent SystemStryker Neurovascular2019-05-16QCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327382235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327382235076133273822357613327382235

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
Length30Millimeter
Outer Diameter3Millimeter

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
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
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

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
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
00842429100790LVIS Jr.Microvention, Inc.QCA2018-06-26
00842429100806LVIS Jr.Microvention, Inc.QCA2018-06-26