Catalog Number

-

Brand Name

Excalibur 200 TRUE micrometer laser fiber

Version/Model Number

SU-200-TRUE-EX

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

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

440d833b-1278-4050-a2bc-c44f25f2f29b

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 13, 2020

Package DI Number

B145116110

Quantity per Package

5

Contains DI Package

B145116090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton