Catalog Number

MRPP80ALN

Brand Name

Pro-Fuse® Low Profile CT Port

Version/Model Number

MRPP80ALN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2021

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

b178c69a-15af-49fc-809c-22fbefc87f15

Public Version Date

September 17, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

50884908149994

Quantity per Package

5

Contains DI Package

00884908149999

Package Discontinue Date

July 13, 2021

Package Status

Not in Commercial Distribution

Package Type

box