Catalog Number

PDD

Brand Name

Stronghold

Version/Model Number

PDD

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JAY

Product Code Name

Support, Breathing Tube

Public Device Record Key

c86f155c-1a12-4bca-a255-752c46fffed5

Public Version Date

October 04, 2019

Public Version Number

1

DI Record Publish Date

September 26, 2019

Package DI Number

00860002529059

Quantity per Package

20

Contains DI Package

00860002529028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box