RtDosePlan - MATH RESOLUTIONS, LLC

Duns Number:021888258

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More Product Details

Catalog Number

-

Brand Name

RtDosePlan

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K022961

Product Code Details

Product Code

MUJ

Product Code Name

System,Planning,Radiation Therapy Treatment

Device Record Status

Public Device Record Key

a9024804-c560-44a8-9766-06f6c77dc14a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MATH RESOLUTIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6