Catalog Number

-

Brand Name

Gongdong

Version/Model Number

GDF-01

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"

Yes

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

b77f6929-dcec-431d-a185-a20407b82759

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Package DI Number

16947462492145

Quantity per Package

10

Contains DI Package

06947462492148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag