Catalog Number

O6627

Brand Name

Trinity Biotech

Version/Model Number

O6627

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

K842366

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

5dc7b0a4-d394-41fb-9d5b-a611c9d77f1d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-