Catalog Number

XT001154-1

Brand Name

TC-100

Version/Model Number

XT001154-1

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

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

K993106

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

d9705014-621d-4d66-b2d5-33f31d44f30e

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-