Catalog Number

RR 500

Brand Name

Rapid Rhino

Version/Model Number

RR 500

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

4b13f344-638d-4f41-8ea2-64215dae1030

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

August 29, 2015

Package DI Number

20817470006586

Quantity per Package

20

Contains DI Package

00817470006582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX