Catalog Number

92-7238

Brand Name

Medpor

Version/Model Number

92-7238

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

K981374

Product Code

LYA

Product Code Name

SPLINT, INTRANASAL SEPTAL

Public Device Record Key

8cc83ece-ad85-4d5a-9d03-063ef9b48305

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

May 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-