VISICOIL MR Twin Line - Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a - RADIOMED CORP

Duns Number:036545713

Device Description: Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a 10mm spacer in 21g x 20cm Needle2 - 0.50mm Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a 10mm spacer in 21g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 10mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle.

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More Product Details

Catalog Number

PTTL-050-11021

Brand Name

VISICOIL MR Twin Line

Version/Model Number

PTTL-050-11021

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

K120859

Product Code Details

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Device Record Status

Public Device Record Key

81de5908-a6ee-4572-9351-d68ed1fa5853

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RADIOMED CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 380