Catalog Number

BMAUBURN0NAVY0OPT

Brand Name

Badgley Mischka

Version/Model Number

BM Auburn Navy

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

HQR

Product Code Name

Apparatus, cautery, radiofrequency, ac-powered

Public Device Record Key

a382b3fb-26cf-482a-9429-8f4eadc5154e

Public Version Date

October 17, 2019

Public Version Number

2

DI Record Publish Date

October 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-