Catalog Number

-

Brand Name

EIT ALIF Trial

Version/Model Number

AET31637

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K170503

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

a7f65e6e-c054-46d3-978f-8355c7bd2110

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

January 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-