Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

11-STARTERRHINO

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

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

820ba623-13c9-48ae-8afd-d3a4d930ad1e

Public Version Date

August 23, 2021

Public Version Number

2

DI Record Publish Date

April 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-