AccuBoost® - Shielded Breast Applicator - 4cm Round SDO Bottom - ADVANCED RADIATION THERAPY, LLC

Duns Number:193415051

Device Description: Shielded Breast Applicator - 4cm Round SDO Bottom

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More Product Details

Catalog Number

ART-SDO-4-B

Brand Name

AccuBoost®

Version/Model Number

450200-B0

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

-

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

K062135

Product Code Details

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Device Record Status

Public Device Record Key

283f9d01-bbe6-4d94-a591-d175e89c24f9

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED RADIATION THERAPY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 31