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More Product Details

Catalog Number

T10004

Brand Name

MULTIDOS

Version/Model Number

MULTIDOS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K972211

Product Code Details

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Device Record Status

Public Device Record Key

5dfffd19-d07f-4457-8ae8-2a9e2636b85c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PTW-FREIBURG PHYSIKALISCH-TECHNISCHE WERKSTÄTTEN DR. PYCHLAU GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 169