PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker - The Isoray Cesium-131 Implant Devices combined - ISORAY MEDICAL, INC.

Duns Number:113577485

Device Description: The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.

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More Product Details

Catalog Number

-

Brand Name

PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker

Version/Model Number

PL-8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Device Record Status

Public Device Record Key

dfe9b8d5-bb43-49bd-a4b1-9b621716a1c8

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ISORAY MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 17