Catalog Number

-

Brand Name

BIVALVE SPLINT, LARGE THIN. SHORT - TERM USE UP TO 14 DAYS .25MM UHMW

Version/Model Number

890918

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

f048e958-b643-4aa8-a201-9f29f65bb14e

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 13, 2018

Package DI Number

00821925022157

Quantity per Package

12

Contains DI Package

00821925040304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-