X-Mark Ultra - 0.85mm x 2cm X-MARK ULTRA Preloaded in 18g Needle - RADIOMED CORP

Duns Number:036545713

Device Description: 0.85mm x 2cm X-MARK ULTRA Preloaded in 18g Needle

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More Product Details

Catalog Number

1078

Brand Name

X-Mark Ultra

Version/Model Number

1078

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

466e493b-4a9e-47f0-be3f-ad958f3419b6

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