Catalog Number

-

Brand Name

NAMIC

Version/Model Number

91031203

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K163141,K822100,K163141,K822100

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

3e62f29e-e109-42c6-94b0-1e4445925f5b

Public Version Date

April 05, 2019

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

H965910312031

Quantity per Package

25

Contains DI Package

H965910312030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX