Catalog Number

-

Brand Name

Wondfo

Version/Model Number

W1-S3

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K043443,K043443,K043443

Product Code

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Public Device Record Key

a2cd3715-655e-4d95-83c4-1f4d3af51fb2

Public Version Date

October 31, 2022

Public Version Number

2

DI Record Publish Date

February 20, 2020

Package DI Number

00816862021929

Quantity per Package

50

Contains DI Package

00816862021905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-