DIGNITY® - 5F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILICONE - Medical Components, Inc.

Duns Number:038000253

Device Description: 5F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILICONE FILLED SUTURE HOLES W/PRE-ATTACHED Chrono

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More Product Details

Catalog Number

MRDP50PMS

Brand Name

DIGNITY®

Version/Model Number

MRDP50PMS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2021

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

e0788e38-a7b2-409f-96ae-a44c332fdbf6

Public Version Date

February 10, 2021

Public Version Number

2

DI Record Publish Date

November 28, 2019

Additional Identifiers

Package DI Number

50884908149796

Quantity per Package

5

Contains DI Package

00884908149791

Package Discontinue Date

January 14, 2021

Package Status

Not in Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560