Catalog Number

-

Brand Name

Gongdong

Version/Model Number

GD4834T

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNI

Product Code Name

Container, Specimen, Non-Sterile

Public Device Record Key

76f1b0a4-e040-4ec9-8886-44fdfb19f9c1

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Package DI Number

16947462400270

Quantity per Package

400

Contains DI Package

06947462400273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton