Catalog Number

DMRC3S915

Brand Name

C3 WAVE SYSTEMC3 WAVE SYSTEM

Version/Model Number

DMRC3S915

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

Issuing Agency

In GS1

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

LJS

Product Code Name

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

Public Device Record Key

2aadc6d8-a0a2-4761-ab58-d96fe951fcc8

Public Version Date

February 09, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2019

Package DI Number

50884908146900

Quantity per Package

1

Contains DI Package

00884908146905

Package Discontinue Date

January 26, 2021

Package Status

Not in Commercial Distribution

Package Type

box