Catalog Number

SP20.8.16

Brand Name

SurePredict(R)

Version/Model Number

1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

d830a9df-71da-4c1f-ab46-e5774df191cf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2016

Package DI Number

00863772000315

Quantity per Package

20

Contains DI Package

00863772000322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag