Catalog Number

-

Brand Name

AED

Version/Model Number

8780D

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

-

Product Code

CCW

Product Code Name

LARYNGOSCOPE, RIGID

Public Device Record Key

1e58aa6d-9bcd-4ded-8ee3-187fbce22aca

Public Version Date

December 14, 2018

Public Version Number

3

DI Record Publish Date

November 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-