Steady Pro - Steady Pro (Mechanical probe holder and - KOELIS

Duns Number:290318455

Device Description: Steady Pro (Mechanical probe holder and supports)The steady pro range is intended to relia Steady Pro (Mechanical probe holder and supports)The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention.

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More Product Details

Catalog Number

-

Brand Name

Steady Pro

Version/Model Number

KPHA.OO.EC

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

d72957ac-39b4-4060-bfb2-8f42605c4ef4

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOELIS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13