Catalog Number

-

Brand Name

Wondview

Version/Model Number

W39-S

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133343,K133343,K133343

Product Code

GTY

Product Code Name

Antigens, All Groups, Streptococcus Spp.

Public Device Record Key

711ff772-c7a8-443b-acba-f56e6e0cbf36

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 12, 2018

Package DI Number

10816862021056

Quantity per Package

20

Contains DI Package

00816862021059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-