AccessGUDID - DEVICE: HMC-Anomaloskop (MR) (04049584006875)

GUDID

Device Identifier (DI) Information

Brand Name: HMC-Anomaloskop (MR)
Version or Model: 47700
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Primary DI Number: 04049584006875
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317138956 *Terms of Use

Device Description: HMC-Anomaloskop (MR)

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):	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?
16342	Anomaloscope	A mains electricity (AC-powered) ophthalmic instrument used to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects. It typically consists of two different light sources, one that permits the mixing of proportions of red and green and the other is a standard yellow colour which can be brightness adjusted. These are viewed and subsequently matched by the patient and according to the match, red- versus green-blindness, dichromacy versus anomalous trichromacy, and the severity of colour deficiency can be established. This device may be connected to a computer with dedicated application software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIW	Anomaloscope

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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85985592-1be5-44dc-b800-4153b925827e
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022