Catalog Number

LR1045CCD

Brand Name

BLUEWAVE

Version/Model Number

LR1045CCD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K141838

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

59c61615-4d5a-4823-96c1-7046f1034944

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-