Catalog Number

-

Brand Name

Goldeep

Version/Model Number

S12

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212180,K212180

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

50140dbe-d306-4728-ac99-122ef8c63b57

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Package DI Number

06973493599860

Quantity per Package

24

Contains DI Package

06973493598016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton