CT HeadFix 1105

GUDID 07640178060081

Positioning aid for head fixation in the CT head holder.

Pearl Technology AG

Radiological headrest

• Primary Device ID: 07640178060081
• NIH Device Record Key: 3197b4c6-0596-4d60-a5a8-4b18d8628b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT HeadFix
• Version Model Number: CT HeadFix
• Catalog Number: 1105
• Company DUNS: 480151859
• Company Name: Pearl Technology AG
• 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: 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

Customer Support Contacts

• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch
• Phone: +41435350840
• Email: info@pearl-technology.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640178060081 [Primary]

FDA Product Code

• IWY: Holder, Head, Radiographic

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: 2022-05-19
• Device Publish Date: 2022-05-11

Devices Manufactured by Pearl Technology AG

• 07640178061811 - pearltec: 2025-08-05 Patient positioning aid for MR and CT imaging.
• 07640178062078 - pearltec: 2025-08-05 Positioning aid for infants (5-9kg) during MRI and CT.
• 07640178062160 - MR Safety Pad: 2025-08-05 Positioning aid to prevent direct gantry contact in MRI
• 07640178062177 - pearltec: 2025-08-05 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178061477 - Cover Multipad: 2022-05-20 Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging.
• 07640178060012 - Crania Adult: 2022-05-19 Head positioning aid for MR imaging.
• 07640178060029 - Crania Child: 2022-05-19 Head positioning aid for MR imaging.
• 07640178060036 - Multipad Standard: 2022-05-19 Universal patient positioning aid for MR and CT imaging.