Catalog Number

PH-635-70-D

Brand Name

PHASOR

Version/Model Number

PH-635-70-D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 20, 2120

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

bd9c693c-8a4c-49bb-b0d0-68836085dce4

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

May 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-