Catalog Number

-

Brand Name

Cenefom

Version/Model Number

NP-EL15

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

336baa29-3593-4ded-90d4-2a655dd1f352

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

04711552920321

Quantity per Package

50

Contains DI Package

04711552920314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Catron