Catalog Number

CCM1916AN

Brand Name

Progreat Lambda

Version/Model Number

CC*M1916AN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K211078,K211078

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

d118481f-089a-4856-a368-22943033af8f

Public Version Date

April 15, 2022

Public Version Number

1

DI Record Publish Date

April 07, 2022

Package DI Number

54987350741009

Quantity per Package

5

Contains DI Package

04987350741004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton