AccessGUDID - DEVICE: Steady Pro (03665134000738)

GUDID

Device Identifier (DI) Information

Brand Name: Steady Pro
Version or Model: KSP.ARM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOELIS

Primary DI Number: 03665134000738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 290318455 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62379	Surgical instrument assist arm system, manually-adjusted	A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171040	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b3a00f6-4942-483e-869d-c09ba536db1e
Public Version Date: October 14, 2022
Public Version Number: 1
DI Record Publish Date: October 06, 2022