Catalog Number

-

Brand Name

Strapette

Version/Model Number

CP-4404

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

JAY

Product Code Name

Support, Breathing Tube

Public Device Record Key

4454c577-f28c-44a0-8e1d-01d693fa6dbb

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Package DI Number

10709078013079

Quantity per Package

40

Contains DI Package

00709078013072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case