Catalog Number

-

Brand Name

BoneScalpel

Version/Model Number

MXB-S2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

debb1ae7-dcdf-423e-8576-2cbc60f84f45

Public Version Date

February 26, 2020

Public Version Number

2

DI Record Publish Date

March 08, 2018

Package DI Number

10841626102306

Quantity per Package

5

Contains DI Package

00841626102309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box