MEDRAD® Disposable Cervix Coil - " MRInnervu Cervix Coil, Compatible with 1.5 - BAYER MEDICAL CARE INC.

Duns Number:058716649

Device Description: " MRInnervu Cervix Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi.(ENDORECTA " MRInnervu Cervix Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi.(ENDORECTAL CERVIX PROBE,MC)(60727455)"

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More Product Details

Catalog Number

BCR 15

Brand Name

MEDRAD® Disposable Cervix Coil

Version/Model Number

BCR 15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

K930779,K930779

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

7fafd68a-706c-4f24-b69a-9ba2548e2336

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10616258009305

Quantity per Package

5

Contains DI Package

00616258009308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"BAYER MEDICAL CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 360