Catalog Number

ENVISIO-HUD2

Brand Name

EnVisio

Version/Model Number

ENVISIO-HUD2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

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

-

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

K183400

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

ea9b1010-a85f-4876-8525-04293df335c6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-