Catalog Number

-

Brand Name

XTRAC

Version/Model Number

AL 8000 Ultra Plus 7 Series

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K041943

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

dfc47e2e-1828-45ad-b98b-42fef33b6532

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-