Catalog Number

00001

Brand Name

Aurora

Version/Model Number

S11684-12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 22, 2032

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181636

Product Code

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Public Device Record Key

3a285d49-681c-4fa7-8e38-82a10446c27e

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-