PRO-PICC® CT - 4FX55CM SINGLE PRO-PICC® CT BASIC CUTDOWN TRAY - Medical Components, Inc.

Duns Number:038000253

Device Description: 4FX55CM SINGLE PRO-PICC® CT BASIC CUTDOWN TRAY

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More Product Details

Catalog Number

-

Brand Name

PRO-PICC® CT

Version/Model Number

MRCTP41028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Device Record Status

Public Device Record Key

b2566840-4f47-47f0-bf4b-d0ac20ab9fa5

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

May 28, 2016

Additional Identifiers

Package DI Number

50884908118037

Quantity per Package

5

Contains DI Package

00884908118032

Package Discontinue Date

December 14, 2017

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