Catalog Number

BC0516RUN

Brand Name

RELIEVA ULTIRRA NAV

Version/Model Number

BC0516RUN

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

K161698,K161698

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

7afbbf6e-b89f-40ae-9a5e-402a988e081f

Public Version Date

January 22, 2020

Public Version Number

6

DI Record Publish Date

August 01, 2017

Package DI Number

20705031238708

Quantity per Package

5

Contains DI Package

10705031238701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX