Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

10-3000-05KL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EPP

Product Code Name

Splint, Nasal

Public Device Record Key

ece3970d-f2a6-40eb-bcf6-f3d6181f581e

Public Version Date

August 23, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

10385640062173

Quantity per Package

5

Contains DI Package

00385640062176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box