Catalog Number

-

Brand Name

FLEXIBLE REAMER WITH Multiple Flute TIP, 11.5 MM

Version/Model Number

22391

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

K163627

Product Code

HTO

Product Code Name

Reamer

Public Device Record Key

704dd8e3-3ebd-474e-90d7-4368316a6acf

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-