Catalog Number

MIS-IN 42 10-N

Brand Name

SpineArt Bifurcated Universal Fiber Optic Cable

Version/Model Number

011072

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

541f6879-34e2-45cd-aaab-bb6f5ec6762a

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-