Catalog Number

LL28068s

Brand Name

Laser Surgery Fibers and Probes

Version/Model Number

LL28068s

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

Yes

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

K161403,K161403

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

da1e7ea9-69bc-49cc-a4c1-65a3de657083

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Package DI Number

04260155592348

Quantity per Package

5

Contains DI Package

04260155592317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-