Invivo - 1.5T HD T/R Knee Coil (flat base) - INVIVO CORPORATION

Duns Number:009237140

Device Description: 1.5T HD T/R Knee Coil (flat base)

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More Product Details

Catalog Number

-

Brand Name

Invivo

Version/Model Number

45353030472

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

MOS

Product Code Name

Coil, magnetic resonance, specialty

Device Record Status

Public Device Record Key

251bbfd0-f61d-438d-8698-115a33f76fc0

Public Version Date

March 05, 2020

Public Version Number

3

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