Catalog Number

-

Brand Name

Symmetrical Health, LLC

Version/Model Number

cimilre collection kit 32mm

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

118a98c1-45c5-42aa-9a60-743ecd7f5cc2

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-