Catalog Number

5400-030-004

Brand Name

Nasopore

Version/Model Number

5400030004

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

-

Product Code

LYA

Product Code Name

SPLINT, INTRANASAL SEPTAL

Public Device Record Key

57523249-5245-4163-bcf6-36be170e3fef

Public Version Date

March 23, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2018

Package DI Number

37613154340836

Quantity per Package

8

Contains DI Package

07613154340835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack