Catalog Number

-

Brand Name

Goldeep

Version/Model Number

S12-D

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

794322d5-1646-4390-b9d0-bc1593624483

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Package DI Number

06973493594179

Quantity per Package

18

Contains DI Package

06973493597521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-