Catalog Number

SP-79400

Brand Name

SUMMIT MEDICAL

Version/Model Number

SP-79400

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

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

7edfed7c-9911-4dc6-a137-8573e644080e

Public Version Date

August 23, 2021

Public Version Number

2

DI Record Publish Date

April 12, 2021

Package DI Number

10385640064696

Quantity per Package

1

Contains DI Package

00385640064699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX