KIT,STARTER,QUADTRODE CV - INVIVO CORPORATION

Duns Number:013649151

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More Product Details

Catalog Number

989803152261

Brand Name

KIT,STARTER,QUADTRODE CV

Version/Model Number

989803152261

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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

-

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

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Record Status

Public Device Record Key

e6671a80-a216-46d3-aa52-1d7ef3bdf3bd

Public Version Date

March 11, 2021

Public Version Number

5

DI Record Publish Date

December 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INVIVO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 650
U Unclassified 4