Wingspan

Basic Information

• Brand Name: Wingspan
• Primary DI: 04546540722867
• Version / Model: M003WS0400150
• Catalog Number: M003WS0400150
• Company Name: Stryker Corporation
• Labeler DUNS: 042405446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-29
• Public Version: 7
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 5e8c107b-90e1-4315-84b1-1f3aab77c1b1

Device Description

Stent System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJE	intracranial neurovascular stent	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
46352	Bare-metal intracranial vascular stent	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04546540722867	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
H050001	001
H050001	002
H050001	003
H050001	005
H050001	006
H050001	007
H050001	013
H050001	016
H050001	017
H050001	021
H050001	023
H050001	025
H050001	028
H050001	031
H050001	032
H050001	036
H050001	040
H050001	042
H050001	049
H050001	052
H050001	055
H050001	056
H050001	057
H050001	058
H050001	059
H050001	061
H050001	064
H050001	067
H050001	070
H050001	072
H050001	086
H050001	087
H050001	088
H050001	089
H050001	090
H050001	091
H050001	092
H050001	093
H050001	094
H050001	095

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4.0	Millimeter
Length	15.0	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, dark place.