Catalog Number

MRPP66PLN

Brand Name

Pro-Fuse® Low Profile CT Port

Version/Model Number

MRPP66PLN

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"

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

5b20cd50-ef68-43ca-955e-939611373975

Public Version Date

December 04, 2019

Public Version Number

1

DI Record Publish Date

November 26, 2019

Package DI Number

50884908149963

Quantity per Package

5

Contains DI Package

00884908149968

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box