ENFOCUS 4400 VHR 100V

GUDID 00857691006343

Ophthalmic spectral-domain optical coherence tomography system

Primary Device ID	00857691006343
NIH Device Record Key	6827fa47-b0c7-46c7-acf3-b0928c8b1f37
Commercial Distribution Status	In Commercial Distribution
Brand Name	ENFOCUS 4400 VHR 100V
Version Model Number	90-C4450-H2-100
Company DUNS	361420040
Company Name	BIOPTIGEN, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *
Special Storage Condition, Specify	Between 0 and 0 *

Device Issuing Agency	Device ID
GS1	00857691006343 [Primary]

OBO	Tomography, optical coherence

Steralize Prior To Use	false
Device Is Sterile	false