Catalog Number

RPA 550-1

Brand Name

ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH

Version/Model Number

RPA 550-1

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

-

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

K924116

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

09b2217c-eb10-434b-b682-e3f00e4a063a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-