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Phasor

FDA UDI

Class II (US FDA UDI)

by Phasor Health, LLC

Identity

Trade Name
PHASOR FDA UDI
Generic Name
Craniotomy power tool system, battery-powered, single-use FDA UDI
Device Name
Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version A) with Stapler FDA UDI
Model / Reference
PH-635-70 + PH-K-AS FDA UDI
Description
Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version A) with Stapler FDA UDI

Identifiers

Catalog Number
PH-635-70 + PH-K-AS FDA UDI
Primary DI / UDI-DI
B775PH63570PHKAS0 FDA UDI
510(k) Number
K161704 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Craniotomy power tool system, battery-powered, 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

No

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, medicatedCraniotomy power tool system, battery-powered, single-use

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

Similar devices

Also classified as Craniotomy power tool system, battery-powered, single-use.

Cleared under the same submission

K161704 also covers:

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 298ce73d-cf9b-4ffa-942d-539d8813057b 36 fields · synced May 30, 2026