Vista LED - DRE Vista LED, DC - Avante

Duns Number:178440426

Device Description: DRE Vista LED, DC

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More Product Details

Catalog Number

-

Brand Name

Vista LED

Version/Model Number

DRE 061325-V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KZF

Product Code Name

Device, Medical Examination, Ac Powered

Device Record Status

Public Device Record Key

ba043b89-a178-4d9e-ab81-a961ad6012f0

Public Version Date

June 19, 2019

Public Version Number

3

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVANTE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 230