Elana Surgical Kit HUD

FDA UDI

Class Unclassified (US FDA UDI)

by Elana B.V.

Identity

Trade Name: Elana Surgical Kit HUD FDA UDI
Generic Name: Vascular-grafting anastomosis system FDA UDI
Device Name: Elana Surical Kit HUD The Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube. The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity. FDA UDI
Model / Reference: 1 FDA UDI
Description: Elana Surical Kit HUD The Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube. The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity. FDA UDI

Identifiers

Catalog Number: 801-H.00.01 FDA UDI
Primary DI / UDI-DI: M602801H00013 FDA UDI
PMA Number: H080005 FDA UDI
FDA Product Code: PAX FDA UDI
GMDN Term: Vascular-grafting anastomosis system FDA UDI

Classification

Device Class: Unclassified FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Vascular-grafting anastomosis system

Elana Surgical Kit HUD by Elana B.V. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class Unclassified	Pending data

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Manufacturer

Manufacturer: Elana B.V.

Sources (1)

FDA UDI 6c280cf1-7289-4e3a-b03d-f9a17212b889 37 fields · synced May 30, 2026