Catalog Number

-

Brand Name

MEDINAUT-Ix

Version/Model Number

ICD-CA2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

273c2570-2100-48b3-b5b5-87bb6fb2d335

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 13, 2018

Package DI Number

08800038026100

Quantity per Package

10

Contains DI Package

08809317171173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-