BIOM Optic Set disposable, with BIOM HD Flex lens for f=175 mm or f=200 mm

GUDID 04049584008305

BIOM Optic Set disposable, with BIOM HD Flex lens for f=175 mm or f=200 mm

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope Ophthalmic surgical microscope

Primary Device ID	04049584008305
NIH Device Record Key	414f8a1e-4151-45f8-910d-9b7c9207b3eb
Commercial Distribution Status	In Commercial Distribution
Brand Name	BIOM Optic Set disposable, with BIOM HD Flex lens for f=175 mm or f=200 mm
Version Model Number	54415
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584008305 [Package] Contains: 04049584024107 Package: [12 Units] In Commercial Distribution
GS1	04049584024107 [Primary]

FDA Product Code

HOH	Spectacle, Operating (Loupe), Ophthalmic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-14
Device Publish Date	2022-12-06

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