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Phasor

FDA UDI

Class II (US FDA UDI)

by Phasor Health, LLC

Identity

Trade Name
PHASOR FDA UDI
Generic Name
Cerebrospinal fluid external drainage kit FDA UDI
Device Name
Phasor EVAC subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. FDA UDI
Model / Reference
EVAC FDA UDI
Description
Phasor EVAC subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. FDA UDI

Identifiers

Primary DI / UDI-DI
B775EVAC0 FDA UDI
510(k) Number
K243205 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid external drainage kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cerebrospinal fluid external drainage kit

Phasor by Phasor Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebrospinal fluid external drainage kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phasor Health, LLC

Sources (1)

  • FDA UDI 2bf8895d-f0c7-45a7-8747-11ab5afd2154 34 fields · synced May 30, 2026