C9-3 Curved Array Transducer - C9-3 Curved Array Diagnostic Ultrasonic - ZONARE MEDICAL SYSTEMS, INC.

Duns Number:096113340

Device Description: C9-3 Curved Array Diagnostic Ultrasonic Transducer

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More Product Details

Catalog Number

-

Brand Name

C9-3 Curved Array Transducer

Version/Model Number

C9-3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2017

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)

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

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

9e26faac-78cd-41a1-890e-39e7c2b92ecb

Public Version Date

July 21, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZONARE MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22