Catalog Number

SISLGC208

Brand Name

RELIEVA LUMA

Version/Model Number

SISLGC208

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

-

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

EQH

Product Code Name

SOURCE, CARRIER, FIBEROPTIC LIGHT

Public Device Record Key

dd7a8a91-b432-4428-9c29-f57b7c8ef91b

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

September 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-