Catalog Number

-

Brand Name

PHASOR

Version/Model Number

PH-530-70-DT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161704

Product Code

HBE

Product Code Name

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Public Device Record Key

cbaa5869-af1f-4293-9e36-1deba9ba4406

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-