ANTERION

GUDID 04059237000617

Heidelberg Engineering GmbH

Eye anterior segment analyser

• Primary Device ID: 04059237000617
• NIH Device Record Key: 0336ef6e-675a-4d95-9d62-3f5275046101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTERION
• Version Model Number: 88036
• Company DUNS: 329833875
• Company Name: Heidelberg Engineering GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059237000617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211817

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2022-01-11
• Device Publish Date: 2022-01-03

On-Brand Devices [ANTERION]

• 04059237000617: 88036
• 04059237000754: Software with HEYEX 2 V1.2.3
• 04059237000877: 88036
• 04059237000945: Software V.1.2.4 US
• 04059237000938: 88036
• 04059237000952: Software V.1.5 US