Catalog Number

50575

Brand Name

Mediloy M-Ti4

Version/Model Number

50575

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

65ed1590-a05c-4749-b6a0-8cd268141194

Public Version Date

November 25, 2020

Public Version Number

2

DI Record Publish Date

October 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-