Pulsar Vascular PulseRider Aneurysm Neck Reconstruction Device 301-D

GUDID 00859030005116

PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, Y shape

PULSAR VASCULAR, INC.

Bare-metal intracranial vascular stent

• Primary Device ID: 00859030005116
• NIH Device Record Key: 32079d02-f19e-4cd8-9c0f-885062999f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulsar Vascular PulseRider Aneurysm Neck Reconstruction Device
• Version Model Number: 301-D
• Catalog Number: 301-D
• Company DUNS: 065649788
• Company Name: PULSAR VASCULAR, INC.
• 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: false
• Serial Number: true
• 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: 18002552500
• Email: xx@xx.xx
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00859030005116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H160002

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: 4
• Public Version Date: 2019-09-18
• Device Publish Date: 2017-08-31

On-Brand Devices [Pulsar Vascular PulseRider Aneurysm Neck Reconstruction Device]

• 00859030005154: PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, T Shape
• 00859030005147: PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 8 mm, T shape
• 00859030005130: PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 10 mm, T shape
• 00859030005123: Pulsar Vascular PulseRider, 3.5–4.5mm, 10mm, T shape
• 00859030005116: PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 8 mm, Y shape
• 00859030005109: PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 8 mm, Y Shape
• 00859030005093: PulseRider Aneurysm Neck Reconstruction Device, 2.7 to 3.5 mm, 10 mm, Y shape
• 00859030005086: PulseRider Aneurysm Neck Reconstruction Device, 3.5 to 4.5 mm, 10 mm, Y shape