Catalog Number

MODC18854

Brand Name

DEPUY CODMAN

Version/Model Number

MODC18854

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

K914007,K914007

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

dc7bc4a5-0371-4933-99fa-22dab418f403

Public Version Date

September 14, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

20886704044137

Quantity per Package

5

Contains DI Package

10886704044130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX