Catalog Number

-

Brand Name

AED

Version/Model Number

8800AXS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170285

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Public Device Record Key

363c0c13-7f53-4152-92e7-d0af02e854fe

Public Version Date

December 14, 2018

Public Version Number

4

DI Record Publish Date

November 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-