Catalog Number

-

Brand Name

Wondfo

Version/Model Number

W1-S10

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

K150022,K150022,K150022

Product Code

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Public Device Record Key

32efaabf-809c-401c-9c2c-26117e24d6cd

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

August 28, 2018

Package DI Number

10816862021513

Quantity per Package

80

Contains DI Package

00816862021516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-