EUROPROBE - EUROPROBE 3.2 PROBE - EURORAD

Duns Number:271968109

Device Description: EUROPROBE 3.2 PROBE

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More Product Details

Catalog Number

SOE3211-AF-BT

Brand Name

EUROPROBE

Version/Model Number

3.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

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

IZD

Product Code Name

Probe, Uptake, Nuclear

Device Record Status

Public Device Record Key

05785782-daa5-4d4e-a02d-91538d11463f

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EURORAD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34