Catalog Number

475-916L

Brand Name

BREAST REDUCTION MARKER

Version/Model Number

475-916L

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"

Yes

For Single-Use

-

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

-

Product Code

GAF

Product Code Name

Spatula, Surgical, General & Plastic Surgery

Public Device Record Key

a14bbfe4-bc49-40c4-a6e0-7b3b2813f9f5

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

August 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-