Catalog Number

01432

Brand Name

TMM-SI-SOF, Surgical Intervention-Special Operations Forces

Version/Model Number

01432

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

OGW

Product Code Name

Tracheostomy Kit

Public Device Record Key

c106a8f0-f7ac-43d5-821c-213c5616cf16

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-