Catalog Number

XD 8000

Brand Name

UL_INJECT

Version/Model Number

XD 8000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171392,K192872,K210541

Product Code

IZQ

Product Code Name

Injector, contrast medium, automatic

Public Device Record Key

bb1918ab-848f-42f7-8765-bb4881b49850

Public Version Date

April 29, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-