SYMETREX® LTHD CATHETER - 15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS - Medical Components, Inc.

Duns Number:038000253

Device Description: 15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 23CM FRO 15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 23CM FROM TIP )

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More Product Details

Catalog Number

MSPS023

Brand Name

SYMETREX® LTHD CATHETER

Version/Model Number

MSPS023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 2022

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

K202176,K202176

Product Code Details

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Device Record Status

Public Device Record Key

7f90b083-9245-4348-ac77-127ebdaf1e54

Public Version Date

May 10, 2022

Public Version Number

3

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

50884908157050

Quantity per Package

5

Contains DI Package

00884908157055

Package Discontinue Date

April 28, 2022

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