Catalog Number

-

Brand Name

Soloist™

Version/Model Number

448142J

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K190132

Product Code

DRF

Product Code Name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Public Device Record Key

95656fcd-2b71-4f42-b7a9-2a964ac288c0

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-