Catalog Number

-

Brand Name

Septal-H Infant Size

Version/Model Number

CP-5500A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

db4e8c59-a350-41a8-8f51-9b25bfabac50

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 08, 2021

Package DI Number

10709078012690

Quantity per Package

20

Contains DI Package

00709078012693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box