EchoNous Bladder Probe - Refurbished - Extracorporeal ultrasound imaging system - ECHONOUS, INC.

Duns Number:080481089

Device Description: Extracorporeal ultrasound imaging system transducer, hand-held

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More Product Details

Catalog Number

-

Brand Name

EchoNous Bladder Probe - Refurbished

Version/Model Number

R005600

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181574

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

bd8a6cd9-4474-4ad2-aa3b-9e37a7c4817c

Public Version Date

August 28, 2019

Public Version Number

1

DI Record Publish Date

August 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECHONOUS, 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. 46