Catalog Number

-

Brand Name

TRAUS SUS20

Version/Model Number

TRAUS SUS20#2

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192561

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Public Device Record Key

8f3bf93e-eb42-44ea-a439-b5b0a4af7b90

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-