Catalog Number

SD980.108

Brand Name

TRUMATCH

Version/Model Number

SD980.108

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

K173039

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

02fa28d4-82b7-4d47-844a-9107ec429105

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-