Light Cable for VS3 System - VISIONSENSE LTD.

Duns Number:532199478

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More Product Details

Catalog Number

560-6462

Brand Name

Light Cable for VS3 System

Version/Model Number

VS3-IR

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152204,K183453,K191851

Product Code Details

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Device Record Status

Public Device Record Key

2896d17c-f7e2-45d2-bc2e-746e58199730

Public Version Date

July 13, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISIONSENSE LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 77