ANTERION

GUDID 04059237000754

Heidelberg Engineering GmbH

Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser

• Primary Device ID: 04059237000754
• NIH Device Record Key: ec3cc072-ebbd-4e6f-86a6-c4a95d95662f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTERION
• Version Model Number: Software with HEYEX 2 V1.2.3
• 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: false
• 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	04059237000754 [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: 2022-02-22
• Device Publish Date: 2022-02-14

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