DEVICE: NEUROFORM EZ 3 (04546540697813)
Device Identifier (DI) Information
NEUROFORM EZ 3
M003N3EZ35300
In Commercial Distribution
M003N3EZ35300
Stryker Corporation
M003N3EZ35300
In Commercial Distribution
M003N3EZ35300
Stryker Corporation
Stent System
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NJE | intracranial neurovascular stent |
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in cool, dry, dark place. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30.0 Millimeter |
Outer Diameter: 3.5 Millimeter |
Device Record Status
1a7ee495-2f26-4aec-8b14-604342b4c03c
February 05, 2021
8
May 29, 2015
February 05, 2021
8
May 29, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)916-3876
NVCustomerService@stryker.com
NVCustomerService@stryker.com