Catalog Number

-

Brand Name

EasyTip Endo Pack 25

Version/Model Number

6535905

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

8d955713-0dc8-4212-b11b-de83c27b857a

Public Version Date

May 17, 2022

Public Version Number

2

DI Record Publish Date

March 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-