Intermedic 41155

GUDID 08435259605256

Laser diode 980nm for Ophthalmology

INTERMEDIC ARFRAN SA

General/multiple surgical diode laser system

• Primary Device ID: 08435259605256
• NIH Device Record Key: 1e624c5f-14eb-44b6-8133-d9dac3e9c621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intermedic
• Version Model Number: Multidiode OFT
• Catalog Number: 41155
• Company DUNS: 863230454
• Company Name: INTERMEDIC ARFRAN 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435259605256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053540

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-10-10

On-Brand Devices [Intermedic]

• 08435259605256: Laser diode 980nm for Ophthalmology
• 08435259605218: Surgical laser diode 980nm for soft tissue