Invivo - Breast MRI 8ch Tabletop for Siemens 1.5T - INVIVO CORPORATION

Duns Number:009237140

Device Description: Breast MRI 8ch Tabletop for Siemens 1.5T

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Invivo

Version/Model Number

45353038349

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

7c10166c-9cfb-4bf9-bd7b-8ee1cdf92c59

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