Catalog Number

BC0616RU

Brand Name

RELIEVA ULTIRRA

Version/Model Number

BC0616RU

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

K111254,K111254

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

c5b5199c-0574-4731-8a28-d3b609a0e7d6

Public Version Date

January 22, 2020

Public Version Number

6

DI Record Publish Date

October 01, 2016

Package DI Number

20705031200279

Quantity per Package

5

Contains DI Package

10705031200272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX