SPECTRALIS, HEP

GUDID 04059237000396

Heidelberg Engineering GmbH

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• Primary Device ID: 04059237000396
• NIH Device Record Key: 9ab328b4-2a25-45ed-adaf-dd230891b80e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECTRALIS, HEP
• Version Model Number: Image Capture Module SW V1.2.4
• 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	04059237000396 [Primary]

FDA Product Code

• HOO: Perimeter, 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: 2018-08-13
• Device Publish Date: 2018-07-11

Devices Manufactured by Heidelberg Engineering GmbH

• 04059237000938 - ANTERION: 2023-11-27
• 04059237000945 - ANTERION: 2023-11-27
• 04059237000730 - HRT3: 2023-03-13
• 04059237000884 - SPECTRALIS: 2022-11-03
• 04059237000891 - SPECTRALIS: 2022-11-03
• 04059237000877 - ANTERION: 2022-10-07
• 04059237000754 - ANTERION: 2022-02-22
• 04059237000815 - SPECTRALIS: 2022-02-10