Catalog Number

-

Brand Name

Dr. Talbot's

Version/Model Number

1100

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

-

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

1d177991-ce25-487e-86e0-b54e4be9b63e

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Package DI Number

20370797011003

Quantity per Package

6

Contains DI Package

00370797011009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-