Catalog Number

RUS940

Brand Name

Coloplast

Version/Model Number

RUS940

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182831

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

f9b51bfb-9ff2-4af2-a043-8df06656fd95

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-