BIOM Optic Set, HD Flex 54025

GUDID 00852475007158

Diagnostic condensing lens

Primary Device ID	00852475007158
NIH Device Record Key	7b0c53df-d467-43fe-9b22-e63e23b65ac4
Commercial Distribution Status	In Commercial Distribution
Brand Name	BIOM Optic Set, HD Flex
Version Model Number	54025
Catalog Number	54025
Company DUNS	015409582
Company Name	OCULUS SURGICAL INC
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

Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00852475007158 [Primary]
GS1	10852475007155 [Package] Package: Case [12 Units] In Commercial Distribution

HJL	Lens, Condensing, Diagnostic

Steralize Prior To Use	false
Device Is Sterile	true

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