Eyer NM-STD

GUDID 07908616100011

Eyer Retinal Camera NM-STD

PHELCOM TECHNOLOGIES SA

Ophthalmic fundus camera

• Primary Device ID: 07908616100011
• NIH Device Record Key: 47465866-2da8-49fb-8273-da2e14b55a68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eyer
• Version Model Number: Eyer NM-STD
• Catalog Number: NM-STD
• Company DUNS: 945005233
• Company Name: PHELCOM TECHNOLOGIES SA
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07908616100011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221329

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [Eyer]

• 07908616100042: Eyer Retinal Camera M-STD
• 07908616100011: Eyer Retinal Camera NM-STD