Catalog Number

ALA-45

Brand Name

Alatus

Version/Model Number

ALA-45 Unit Tray

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"

Yes

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

K092534,K092534,K092534

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

4afb0d97-9885-4eb8-a113-734f27136882

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

10851546007001

Quantity per Package

5

Contains DI Package

00851546007004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box