AccessGUDID - DEVICE: iGUIDE (04056719001704)

GUDID

Device Identifier (DI) Information

Brand Name: iGUIDE
Version or Model: P10603-109
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P10603-109
Company Name: 3C-Medical Intelligence GmbH

Primary DI Number: 04056719001704
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 314546664 *Terms of Use

Device Description: iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module

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?
40687	Accelerator system table, powered	An electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143485	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: 2afc8cff-aad4-4471-a6a0-b8007cb9c0e1
Public Version Date: December 15, 2023
Public Version Number: 5
DI Record Publish Date: August 23, 2016