Catalog Number

72-2057

Brand Name

TRAUMAONE SYSTEM

Version/Model Number

72-2057

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2020

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"

-

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

K062842

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Public Device Record Key

c898b2df-5663-4793-9f5f-0d7c8c0d58d1

Public Version Date

July 30, 2020

Public Version Number

5

DI Record Publish Date

October 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-