FIDUCIAL NEEDLES - BRACHYTHERAPY - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: BRACHYTHERAPY

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More Product Details

Catalog Number

-

Brand Name

FIDUCIAL NEEDLES

Version/Model Number

FN17-53

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103449

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

4e994068-e6b3-4034-b3b5-7756d21f74c3

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RIVERPOINT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 1369
U Unclassified 8