Catalog Number

301-0903

Brand Name

Curaplex

Version/Model Number

301-0903

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

-

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

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Public Device Record Key

a47f4b27-a715-4063-a10d-cc9d275865ce

Public Version Date

December 08, 2020

Public Version Number

1

DI Record Publish Date

November 30, 2020

Package DI Number

00818834028424

Quantity per Package

50

Contains DI Package

00818834028417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box