DEVICE: Neuroform3 (07613252193913)

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Device Record History
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Device Identifier (DI) Information
Neuroform3
M003SNF345100
In Commercial Distribution
M003SNF345100
Stryker Corporation
07613252193913
GS1

1
042405446 *Terms of Use
Microdelivery 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 001
H020002 002
H020002 004
H020002 005
H020002 006
H020002 007
H020002 008
H020002 011
H020002 012
H020002 013
H020002 014
H020002 015
H020002 017
H020002 020
H020002 021
H020002 022
H020002 025
H020002 027
H020002 029
H020002 030
H020002 032
H020002 033
H020002 034
H020002 036
H020002 039
H020002 040
H020002 041
H020002 042
H020002 043
H020002 045
H020002 047
H020002 049
H020002 050
H020002 053
H020002 054
H020002 055
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: 4.5 Millimeter
Length: 10.0 Millimeter
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Device Record Status
b0a07e5c-fe48-4f2a-b8f2-15c15b37759a
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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