Catalog Number

60-315

Brand Name

Custom Nasal Splint

Version/Model Number

60-315

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

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

b00e9b2b-9fb3-4177-a74b-d633942bf65a

Public Version Date

August 30, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2015

Package DI Number

EBES603151

Quantity per Package

10

Contains DI Package

EBES603150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton