Catalog Number

MRPP50ALN

Brand Name

Pro-Fuse® Low Profile CT Port

Version/Model Number

MRPP50ALN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 17, 2020

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"

Yes

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

-

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

fca4612e-f847-4bd4-8c29-b3e428065ea6

Public Version Date

September 15, 2020

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

50884908149901

Quantity per Package

5

Contains DI Package

00884908149906

Package Discontinue Date

July 17, 2020

Package Status

Not in Commercial Distribution

Package Type

box