Catalog Number

PH-270-210

Brand Name

Phasor Drill

Version/Model Number

008-1048

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2020

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

-

Product Code

GFG

Product Code Name

Bit, Surgical

Public Device Record Key

9103a040-437b-43f2-aa5b-d724276e916c

Public Version Date

January 04, 2021

Public Version Number

3

DI Record Publish Date

December 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-