Catalog Number

WP-3840

Brand Name

Water Phantoms with Depth Positioning Assembly

Version/Model Number

WP-3840

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

K173848

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

9b6f7f78-b04a-4dfb-9181-668fd6df691c

Public Version Date

September 27, 2018

Public Version Number

1

DI Record Publish Date

August 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-