Catalog Number

-

Brand Name

Braun Silk Expert Pro 5

Version/Model Number

PL5157

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

30efbcb0-94d4-44d3-93ab-9b934f64b24e

Public Version Date

February 16, 2022

Public Version Number

1

DI Record Publish Date

February 08, 2022

Package DI Number

10069055890070

Quantity per Package

2

Contains DI Package

00069055890523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box