Catalog Number

94301-MI-R

Brand Name

NvisionVLE Marking Console with IRIS, Refurbished

Version/Model Number

94301-MI-R

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

NQQ

Product Code Name

System, Imaging, Optical Coherence Tomography (Oct)

Public Device Record Key

37c05fc1-a427-4992-bb64-383526cd404a

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-