Catalog Number

DMRC3S94

Brand Name

C3 WAVE SYSTEMC3 WAVE SYSTEM

Version/Model Number

DMRC3S94

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2020

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

8938f8aa-881c-4a02-94c9-61788a102b8a

Public Version Date

May 29, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2019

Package DI Number

50884908146955

Quantity per Package

1

Contains DI Package

00884908146950

Package Discontinue Date

May 28, 2020

Package Status

Not in Commercial Distribution

Package Type

box