Catalog Number

-

Brand Name

Septal-H

Version/Model Number

CP-5410

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

0a2b7200-213d-47f1-92d7-b452acc7cf80

Public Version Date

July 30, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2021

Package DI Number

10709078013123

Quantity per Package

80

Contains DI Package

00709078013126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case