Catalog Number

-

Brand Name

Ambu

Version/Model Number

002 810 001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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

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

IQF

Product Code Name

Orthosis, Cervical-Thoracic, Rigid

Public Device Record Key

1c1beec4-a125-43a3-a2b2-a7335f7761ae

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30817357021500

Quantity per Package

30

Contains DI Package

10817357021506

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box