Catalog Number

-

Brand Name

OSYFIBRE

Version/Model Number

PH-EO-980-25-600-3

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

K080731,K080731,K080731

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

506a3d50-d250-43c4-89f3-befd509dde26

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2016

Package DI Number

03760227850167

Quantity per Package

10

Contains DI Package

03760227850150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard