Catalog Number

-

Brand Name

EZX

Version/Model Number

XTL48B

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Public Device Record Key

b9c91b2d-7042-4b55-a9db-9e4e4f5d3bee

Public Version Date

February 12, 2020

Public Version Number

3

DI Record Publish Date

August 03, 2018

Package DI Number

08800038027947

Quantity per Package

10

Contains DI Package

08800038026865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-