AccessGUDID - DEVICE: Adhesive Pad (04260759930515)

GUDID

Device Identifier (DI) Information

Brand Name: Adhesive Pad
Version or Model: E003001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E003001
Company Name: Fiagon GmbH

Primary DI Number: 04260759930515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 312623008 *Terms of Use
Previous DI: EFIAE0030011

Device Description: Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system.

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:	Yes
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?
45199	Multi-purpose stereotactic surgery system	An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGW	Ear, Nose, And Throat Stereotaxic Instrument

FDA Premarket Submission

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

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: ff16ba74-4826-454a-8b3c-f6a7d61ebea1
Public Version Date: September 10, 2024
Public Version Number: 1
DI Record Publish Date: September 02, 2024