Catalog Number

SD980.113

Brand Name

TruMatch

Version/Model Number

SD980.113

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

K170272,K173039

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

190a5c26-2ed4-45aa-952d-c942b2f51a93

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-