Catalog Number

8154114

Brand Name

X-ray Beam Filter Kit

Version/Model Number

X-ray Beam Filter Kit

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K837334,K837334

Product Code

KPW

Product Code Name

Device, beam limiting, x-ray, diagnostic

Public Device Record Key

c20fd719-97e0-4391-8c66-78c3b33264b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

60889978154111

Quantity per Package

20

Contains DI Package

40889978154117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case