Catalog Number

-

Brand Name

UNIVERSAL EXTERNAL NASAL SPLINT, LARGE (6/PK)

Version/Model Number

70890908

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

EPP

Product Code Name

SPLINT, NASAL

Public Device Record Key

080e79e3-6942-426a-abb5-465d29976e54

Public Version Date

May 23, 2019

Public Version Number

2

DI Record Publish Date

September 13, 2018

Package DI Number

00821925030121

Quantity per Package

6

Contains DI Package

00821925034037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-