Gold Fiducial - 3 Pack 1.0mm x 5mm Gold Fiducial Marker - RADIOMED CORP

Duns Number:036545713

Device Description: 3 Pack 1.0mm x 5mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle.

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More Product Details

Catalog Number

GF1823

Brand Name

Gold Fiducial

Version/Model Number

GF1823

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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

7a48ab72-27d4-4184-bca4-a594620705b7

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 26, 2022

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