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Phasor

FDA UDI

Class II (US FDA UDI)

by Phasor Health, LLC

Identity

Trade Name
PHASOR FDA UDI
Generic Name
Cranial trephine, single-use FDA UDI
Device Name
Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapler FDA UDI
Model / Reference
PH-450-70-DT+PH-K-A1S FDA UDI
Description
Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapler FDA UDI

Identifiers

Primary DI / UDI-DI
B775PH45070DTPHKA1S0 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Cranial trephine, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 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: Neurosurgical procedure kit, medicatedCranial trephine, single-use

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

Similar devices

Also classified as Cranial trephine, single-use.

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 ed90fba2-6cf8-4825-ad77-61f1b1d8510d 34 fields · synced Jun 7, 2026