Catalog Number

RSP0616MFSN

Brand Name

RELIEVA SPINPLUS NAV

Version/Model Number

RSP0616MFSN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171687,K171687

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

14b54b4a-21bd-4a45-b9ef-87c843264ba0

Public Version Date

January 22, 2020

Public Version Number

6

DI Record Publish Date

February 18, 2018

Package DI Number

20705031241012

Quantity per Package

5

Contains DI Package

10705031241015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX