Catalog Number

5400-212-004S

Brand Name

Nasopore

Version/Model Number

5400212004s

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

7450c58f-93cb-4c81-bfa9-46d86bc29f62

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

37613327500388

Quantity per Package

2

Contains DI Package

07613327500387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack