Catalog Number

SIS100B

Brand Name

RELIEVA LUMA SENTRY

Version/Model Number

SIS100B

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

K071845,K071845

Product Code

EQH

Product Code Name

SOURCE, CARRIER, FIBEROPTIC LIGHT

Public Device Record Key

f4953e61-72fc-4f5f-a3b7-9052780b7da5

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

October 01, 2016

Package DI Number

20705031135632

Quantity per Package

5

Contains DI Package

10705031135635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX