Catalog Number

-

Brand Name

Hood Nasal Septal Button

Version/Model Number

NSBT-30-S

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

K920994

Product Code

LFB

Product Code Name

Button, Nasal Septal

Public Device Record Key

279fce54-065d-41e0-bc20-3f9a72ab5be6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-