Catalog Number

SSZ-X560

Brand Name

NATRELLE INSPIRA Single Use Sizers

Version/Model Number

SSZ-X560

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203229

Product Code

MRD

Product Code Name

Sizer, Mammary, Breast Implant Volume

Public Device Record Key

060e83f3-365f-4ebe-a3e3-5902a7fbf14b

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-