NEUROFORM EZ 3 M003N3EZ35300

GUDID 04546540697813

Stryker Corporation

Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent

• Primary Device ID: 04546540697813
• NIH Device Record Key: 1a7ee495-2f26-4aec-8b14-604342b4c03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEUROFORM EZ 3
• Version Model Number: M003N3EZ35300
• Catalog Number: M003N3EZ35300
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540697813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020002

FDA Product Code

• NJE: intracranial neurovascular stent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2015-05-29

On-Brand Devices [NEUROFORM EZ 3]

• 07613252193579: M003N3EZ45100
• 07613252193500: M003N3EZ35100
• 04546540697882: M003N3EZ45300
• 04546540697875: M003N3EZ45200
• 04546540697868: M003N3EZ45150
• 04546540697844: M003N3EZ40300
• 04546540697837: M003N3EZ40200
• 04546540697820: M003N3EZ40150
• 04546540697813: M003N3EZ35300
• 04546540697806: M003N3EZ35200
• 04546540697790: M003N3EZ35150
• 04546540697776: M003N3EZ30300
• 04546540697769: M003N3EZ30200
• 04546540697752: M003N3EZ30150
• 04546540697745: M003N3EZ25200
• 04546540697738: M003N3EZ25150