Easyloupe 2,5 x, Titan

GUDID 04049584019417

Easyloupe 2,5 x, Titan

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Magnifying spectacles

Primary Device ID	04049584019417
NIH Device Record Key	253a881e-db2e-41de-9b2b-0b132f65a576
Commercial Distribution Status	In Commercial Distribution
Brand Name	Easyloupe 2,5 x, Titan
Version Model Number	39735
Company DUNS	317138956
Company Name	OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584019417 [Primary]

FDA Product Code

HOI	Spectacle, Magnifying

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-15
Device Publish Date	2022-12-07

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

04049584037695 - Focusing Module BIOM 6, 175 mm	2026-02-02
04049584037701 - Focusing Module BIOM 6, 200 mm	2026-02-02
04049584037718 - Precision Mount for B&L	2026-02-02
04049584037725 - Precision Mount for Leica	2026-02-02
04049584037732 - Precision Mount for Alcon	2026-02-02
04049584037749 - Precision Mount for Zeiss	2026-02-02
04049584037756 - Precision Mount for Haag Streit	2026-02-02
04049584035738 - BIOM 6 HD Optic Set for f=175 mm	2026-01-22