Catalog Number

1627

Brand Name

Motion Medical Distributing

Version/Model Number

1627

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OGP

Product Code Name

Cricothyrotomy Kit

Public Device Record Key

a2cb8125-fbe7-446d-9f63-40208ece87ed

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 25, 2017

Package DI Number

25060498451745

Quantity per Package

10

Contains DI Package

15060498451748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case