Breast BI 7 MR Coil Set 1.5T - The intended use of the Breast BI 7 MR Coil Set - Noras MRI products GmbH

Duns Number:312844095

Device Description: The intended use of the Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Re The intended use of the Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast.

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More Product Details

Catalog Number

118984

Brand Name

Breast BI 7 MR Coil Set 1.5T

Version/Model Number

04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180123

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

ee57ee31-a6a8-40b9-8e53-818a9bd6139a

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORAS MRI PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 518