DEVICE: Wingspan (04546540722799)

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Device Record History
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Device Identifier (DI) Information
Wingspan
M003WS0300090
In Commercial Distribution
M003WS0300090
Stryker Corporation
04546540722799
GS1

1
042405446 *Terms of Use
Stent System
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Device Characteristics
MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NJE intracranial neurovascular stent
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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
H050001 089
H050001 090
H050001 091
H050001 092
H050001 093
H050001 094
H050001 095
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in cool, dry, dark place.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 3.0 Millimeter
Length: 9.0 Millimeter
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Device Record Status
d7e49bd5-355b-4e01-b8f6-4e941defb106
February 05, 2021
7
May 29, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)916-3876
NVCustomerService@stryker.com
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