Catalog Number

60-301

Brand Name

Bivalve Nasal Splint, Standard

Version/Model Number

60-301

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K972096,K972096

Product Code

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

e600c002-56fd-45f4-94da-502aee5fa9a4

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

34063107102296

Quantity per Package

10

Contains DI Package

14063107102292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton