Catalog Number

-

Brand Name

iTX Extremity 18 Flare

Version/Model Number

11293128

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

K183221

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

bd54bb7d-2352-4243-8d35-d22310a10710

Public Version Date

November 17, 2021

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-