DEVICE: NEUROFORM EZ 3 (04546540697875)

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Device Record History
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Device Identifier (DI) Information
NEUROFORM EZ 3
M003N3EZ45200
In Commercial Distribution
M003N3EZ45200
Stryker Corporation
04546540697875
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 [?]
H020002 016
H020002 017
H020002 020
H020002 021
H020002 023
H020002 024
H020002 026
H020002 027
H020002 028
H020002 029
H020002 030
H020002 032
H020002 033
H020002 034
H020002 036
H020002 037
H020002 038
H020002 042
H020002 044
H020002 048
H020002 053
H020002 055
H020002 056
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
Length: 20.0 Millimeter
Outer Diameter: 4.5 Millimeter
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Device Record Status
8ae7a392-ba98-4d90-ae0a-89eb3f5aabcc
February 05, 2021
8
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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