AccessGUDID - DEVICE: Easyfield S (04049584000064)

GUDID

Device Identifier (DI) Information

Brand Name: Easyfield S
Version or Model: 15005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Primary DI Number: 04049584000064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317138956 *Terms of Use

Device Description: The OCULUS Easyfield® has been designed for combined use as a screening unit with all associated options for immediate follow-up examination of suspicious findings. The most common examination grids and strategies for the central visual field up to 30° can be accessed. The Easyfield® offers pre programmed combinations for often needed examination routines. For example: Screening 24-2, SPARK Quick, Macula. You can also combine your own routines and then save them as a program.

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?
16918	Perimeter, automatic	A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOO	Perimeter, Ac-Powered

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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 4.6 Kilogram
Height: 435 Millimeter
Depth: 450 Millimeter
Width: 275 Millimeter

Device Record Status

Public Device Record Key: a60ba644-197f-46da-9b9c-ec10c76d383b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016