Catalog Number

21116W

Brand Name

DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE

Version/Model Number

21116W

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"

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

K953513,K953513

Product Code

IYT

Product Code Name

System, rebreathing, radionuclide

Public Device Record Key

e2dc774c-02e1-4f84-abc9-0f345b74110d

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102610

Quantity per Package

20

Contains DI Package

00612649185781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-