Catalog Number

71143107

Brand Name

TC-100

Version/Model Number

71143107

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,K993106

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

c1d604f5-82ee-49c9-a752-d31a453b4a3a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

23596010387350

Quantity per Package

6

Contains DI Package

03596010387356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX