AccessGUDID - DEVICE: Connexion (04056719001230)

GUDID

Device Identifier (DI) Information

Brand Name: Connexion
Version or Model: P10105-250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10105-250
Company Name: 3C-Medical Intelligence GmbH

Primary DI Number: 04056719001230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314546664 *Terms of Use

Device Description: The removable accessory rails are positioned along the superior lateral area of the Connexion™ Imaging Module and the Connexion™ Central Opening Module. They are designed to be simply and easily removed between treatments.

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?
40686	Accelerator system table, non-powered	A non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs with fixed position top or mechanical top positioning and/or height controls (e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms). 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
IXQ	Table, Radiographic, Stationary Top

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 09c87364-251e-4ab9-8e16-2b1c5085831b
Public Version Date: December 15, 2023
Public Version Number: 4
DI Record Publish Date: August 23, 2016