iCam 700-49517-003

GUDID 00858848006339

iCam Camera Head 5 MP

OPTOVUE, INC.

Ophthalmic fundus camera

• Primary Device ID: 00858848006339
• NIH Device Record Key: 4eb8487e-9a51-4943-92bb-4cc0b719ab08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCam
• Version Model Number: iCam100
• Catalog Number: 700-49517-003
• Company DUNS: 196500461
• Company Name: OPTOVUE, 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

Customer Support Contacts

• Phone: 866-941-9240
• Email: service@optovue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858848006339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122572

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-07

On-Brand Devices [iCam]

• 00858848006414: iCam Camera Head 5MP
• 00858848006339: iCam Camera Head 5 MP
• 00858848006322: iCam Camera Head 5 MP
• 00858848006278: iCam Camera Head 5 MP
• 00858848006780: iCam 12 MP