Catalog Number

-

Brand Name

BoneScalpel

Version/Model Number

MXB-S1

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

88fbb87d-5169-4d5d-aec8-90c500742c47

Public Version Date

February 26, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10841626101217

Quantity per Package

5

Contains DI Package

00841626101210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box