VT1 - FIM MEDICAL

Duns Number:577219207

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More Product Details

Catalog Number

-

Brand Name

VT1

Version/Model Number

Software

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 30, 2022

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HOX

Product Code Name

Chart, Visual Acuity

Device Record Status

Public Device Record Key

ba29ee5c-3d7b-45e5-b642-e7fbaa5c9f30

Public Version Date

June 09, 2022

Public Version Number

3

DI Record Publish Date

October 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIM MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 6