Catalog Number

-

Brand Name

Gongdong

Version/Model Number

GDC-01-F

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

K082042,K082042

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

46c26994-0502-471c-a287-5a87d8497646

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

16947462491544

Quantity per Package

60

Contains DI Package

06947462491547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case