Catalog Number

AS860

Brand Name

AMSure® Tracheostomy Care Tray

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

74ab99cb-1d0c-41b0-830c-dca56b9a3781

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

October 30, 2017

Package DI Number

40704411006399

Quantity per Package

20

Contains DI Package

10704411006398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case