VISICOIL - 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge - RADIOMED CORP

Duns Number:036545713

Device Description: 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.

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More Product Details

Catalog Number

VC-075-020-PL12

Brand Name

VISICOIL

Version/Model Number

VC-075-020-PL12

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

K070305

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

f17c8dc1-a0fc-4915-8056-83b8b7c9470a

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