Wingspan

Primary DI
04546540722904
Brand
Wingspan
Company
Stryker Corporation
Model
M003WS0450200
Catalog number
M003WS0450200
Device description
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
H050001001
H050001002
H050001003
H050001005
H050001006
H050001007
H050001013
H050001016
H050001017
H050001021
H050001023
H050001025
H050001028
H050001031
H050001032
H050001036
H050001040
H050001042
H050001049
H050001052
H050001055
H050001056
H050001057
H050001058
H050001059
H050001061
H050001064
H050001067
H050001070
H050001072
H050001086
H050001087
H050001088
H050001089
H050001090
H050001091
H050001092
H050001093
H050001094
H050001095

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H050001001
H050001002
H050001003
H050001005
H050001006
H050001007
H050001013
H050001016
H050001017
H050001021
H050001023
H050001025
H050001028
H050001031
H050001032
H050001036
H050001040
H050001042
H050001049
H050001052
H050001055
H050001056
H050001057
H050001058
H050001059
H050001061
H050001064
H050001067
H050001070
H050001072
H050001086
H050001087
H050001088
H050001089
H050001090
H050001091
H050001092
H050001093
H050001094
H050001095

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540722904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540722904045465407229044546540722904

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 Diameter4.5Millimeter

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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