Catalog Number

-

Brand Name

DxTx Medical 1.5T eCoil Imaging System Disposables (Cervix)

Version/Model Number

BCR 15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K952235,K952235

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

64866a2b-286a-4402-a5b0-6a8abf5f0f4f

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Package DI Number

10850011472139

Quantity per Package

5

Contains DI Package

00850011472132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-