AccessGUDID - DEVICE: Wingspan (04546540722775)

GUDID

Device Identifier (DI) Information

Brand Name: Wingspan
Version or Model: M003WS0250150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M003WS0250150
Company Name: Stryker Corporation

Primary DI Number: 04546540722775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042405446 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bare-metal intracranial vascular stent	A 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.

GMDN Preferred Term Name

GMDN Definition

Bare-metal intracranial vascular stent

A 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.

FDA Product Code

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Product Code	Product Code Name
NJE	intracranial neurovascular stent

FDA Premarket Submission

FDA Premarket 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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in cool, dry, dark place.

Clinically Relevant Size

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Size Type Text
Length: 15.0 Millimeter
Outer Diameter: 2.5 Millimeter

Device Record Status

Public Device Record Key: ce61c3d6-203a-40f2-8657-5753e15693f5
Public Version Date: November 19, 2018
Public Version Number: 4
DI Record Publish Date: May 29, 2015