FDA.reportPublic FDA data

Neuroform3

Primary DI
07613252193807
Brand
Neuroform3
Company
Stryker Corporation
Model
M003SNF325200
Catalog number
M003SNF325200
Device description
Microdelivery Stent System
Published
2015-05-29
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020002001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020002001

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252193807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252193807076132521938077613252193807

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
Length20Millimeter
Outer Diameter2.5Millimeter

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
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
07613327416312Precision IE 4K0502-275-0100502-275-0102019-01-21
07613327416329Precision IE 4K0502-274-0100502-274-0102019-01-21
07613327416336Precision IE 4K0502-234-0300502-234-0302019-01-21
07613327416343Precision IE 4K0502-276-0700502-276-0702019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859030005253PulseRiderMedos International SàrlNJE2019-09-17
00859030005260PulseRider Aneurysm Neck Reconstruction Device Connection CableMedos International SàrlNJE2019-09-17
00816777025982LVISMicrovention, Inc.NJE2018-11-25
00816777025999LVISMicrovention, Inc.NJE2018-11-25
00816777026002LVISMicrovention, Inc.NJE2018-11-25
00816777026019LVISMicrovention, Inc.NJE2018-11-25
00816777026026LVISMicrovention, Inc.NJE2018-11-25
00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
00810170016301LVISMicrovention, Inc.NJE2018-11-25
00810170016318LVISMicrovention, Inc.NJE2018-11-25
00810170016325LVISMicrovention, Inc.NJE2018-11-25
00810170016332LVISMicrovention, Inc.NJE2018-11-25
00810170016349LVISMicrovention, Inc.NJE2018-11-25
00810170018510LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018527LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018619LVISMicrovention, Inc.NJE2018-11-25
00810170018626LVISMicrovention, Inc.NJE2018-11-25
00810170018961LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018978LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018985LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018992LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170019005LVISMicrovention, Inc.NJE2018-11-25
00810170019012LVISMicrovention, Inc.NJE2018-11-25
00810170019029LVISMicrovention, Inc.NJE2018-11-25
00810170019036LVISMicrovention, Inc.NJE2018-11-25