Catalog Number

-

Brand Name

Single use surgical optical fiber

Version/Model Number

BO000013

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

K163449,K163449,K163449

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

30bf0e7c-a7ef-43b7-8f23-1eb7870ffd0d

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

February 16, 2018

Package DI Number

08051272101089

Quantity per Package

2

Contains DI Package

08051272101072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box