E-Z-SCAN Low Viscosity UltraSound Gel - EZ Scan 8oz Tube - BRACCO DIAGNOSTICS INC

Duns Number:849234661

Device Description: EZ Scan 8oz Tube

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More Product Details

Catalog Number

601002

Brand Name

E-Z-SCAN Low Viscosity UltraSound Gel

Version/Model Number

601002

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Device Record Status

Public Device Record Key

2c5c468b-93a0-4677-bb28-f690ab93e6eb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

30815112020546

Quantity per Package

12

Contains DI Package

10815112020542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BRACCO DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 28