Steady Pro

GUDID 03665134000738

Steady Pro Probe Holding Arm with I and U extension and rail clamping base The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.

KOELIS

Surgical instrument assist arm system, manually-adjusted
Primary Device ID03665134000738
NIH Device Record Key1b3a00f6-4942-483e-869d-c09ba536db1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteady Pro
Version Model NumberKSP.ARM
Company DUNS290318455
Company NameKOELIS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103665134000738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-14
Device Publish Date2022-10-06

On-Brand Devices [Steady Pro]

03665134000592Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably m
03665134000806Universal clamping base The steady pro range is intended to reliably maintain the position of a
03665134000783Probe holder for transrectal approach
03665134000745Probe holder for transperineal approach. The steady pro range is intended to reliably maintain t
03665134000738Steady Pro Probe Holding Arm with I and U extension and rail clamping base The Steady Pro range
03665134000936Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain t

Trademark Results [Steady Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STEADY PRO
STEADY PRO
75907426 not registered Dead/Abandoned
Golf Systems, Inc.
2000-02-01

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