AccessGUDID - DEVICE: Eye Tracker Camera (07090042052023)

GUDID

Device Identifier (DI) Information

Brand Name: Eye Tracker Camera
Version or Model: ETC 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nordicneurolab AS

Primary DI Number: 07090042052023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 671280238 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
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?
12609	Eye movement analysis system	An assembly of mains electricity (AC-powered) devices designed to measure, evaluate and record the movement of the eyes. The device is intended to measure ocular dynamics, typically measuring both horizontal and vertical eye movements. This device can include a stimulus source (e.g., a light bar), a sensing device (e.g., video or infrared cameras), a computer, and a recorder. Some systems may include cameras and/or eyelid trackers mounted on spectacles or headbands.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092253	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: 7682f94e-cc92-4acb-baf7-4df3b86dfb58
Public Version Date: June 02, 2020
Public Version Number: 4
DI Record Publish Date: December 31, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4755707095
Email: customerservice@nordicneurolab.com

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