Invivo - 1.0T Quadrature Lower Extremity Coil - INVIVO CORPORATION

Duns Number:009237140

Device Description: 1.0T Quadrature Lower Extremity Coil

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More Product Details

Catalog Number

-

Brand Name

Invivo

Version/Model Number

472GE-42

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Device Record Status

Public Device Record Key

a9fc0883-d874-43f5-a678-a4797969aabc

Public Version Date

July 19, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

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