Catalog Number

-

Brand Name

InSitu Coil, 3T

Version/Model Number

InSitu Coil, Open 3T

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)

-

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

K123091,K123091

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

2c546850-a32e-4e85-a1bd-69d71323b2d8

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

10857534006377

Quantity per Package

5

Contains DI Package

00857534006370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case