VueLite - VueLite ACMI Scope Adapter - COOK INCORPORATED

Duns Number:042823948

Device Description: VueLite ACMI Scope Adapter

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More Product Details

Catalog Number

VL-AA

Brand Name

VueLite

Version/Model Number

G34311

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2019

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

Yes

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 Details

Product Code

NTN

Product Code Name

Led light source

Device Record Status

Public Device Record Key

4e3a1c82-9183-411c-b58a-d07800e3cbd5

Public Version Date

February 05, 2019

Public Version Number

3

DI Record Publish Date

August 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242