Catalog Number

-

Brand Name

PREGABLE

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 11, 2021

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

-

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

1c7c0b51-e7c0-4cde-90f2-ac1ab9f8e84d

Public Version Date

June 11, 2021

Public Version Number

2

DI Record Publish Date

June 02, 2021

Package DI Number

16970429840161

Quantity per Package

3

Contains DI Package

06970429840164

Package Discontinue Date

June 11, 2021

Package Status

Not in Commercial Distribution

Package Type

-