Catalog Number

-

Brand Name

PhenomTM 21 Catheter

Version/Model Number

FG13150-0615-2S

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

K210230

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

6a31d86c-ad15-4868-ad8f-4b1b437512dd

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-