Catalog Number

-

Brand Name

Chrono-log

Version/Model Number

299-3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K945414,K945414,K945414,K945414,K945414,K945414,K945414,K945414,K945414

Product Code

GGP

Product Code Name

Test, Qualitative And Quantitative Factor Deficiency

Public Device Record Key

6208ec03-c822-488f-9cc5-7d29f66423c2

Public Version Date

September 06, 2019

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

811476010925

Quantity per Package

9

Contains DI Package

00811476010291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-