Sectra Calibration Unit

GUDID 07350092810395

The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition. The calibration markers will be visible on the x-ray images and are intended to serve as scaling references. Typical users of the device are trained professionals, for example radiology technicians.

Sectra AB

General-purpose diagnostic x-ray phantom, test object

• Primary Device ID: 07350092810395
• NIH Device Record Key: 280e427c-bbba-44bf-9567-c663f49090af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Calibration Unit
• Version Model Number: 2
• Company DUNS: 354117848
• Company Name: Sectra AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810395 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

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: 2022-11-15
• Device Publish Date: 2022-11-07

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• 07350092810470 - Sectra Workstation: 2023-11-20 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an