Catalog Number

-

Brand Name

Braun Silk Expert Mini

Version/Model Number

PL1014

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

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

87e34b1f-4b12-4604-b8d3-3c27febe7e08

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Package DI Number

10069055889890

Quantity per Package

2

Contains DI Package

00690558898930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box