AccessGUDID - DEVICE: Eye adapter TOF3D (EMIP57501025)

GUDID

Device Identifier (DI) Information

Brand Name: Eye adapter TOF3D
Version or Model: 5750102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5750102
Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH

Primary DI Number: EMIP57501025
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 324416379 *Terms of Use

Device Description: No description.

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?
62743	Sensor holder, single-use	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOI	Stimulator, Nerve, Peripheral, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212434	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: 2ac5bcfd-e8dd-46eb-9c0a-f373abf5b77a
Public Version Date: June 19, 2026
Public Version Number: 2
DI Record Publish Date: May 30, 2022