PearlFit Cushion 50x20x4 Vac 1131

GUDID 07640178060319

Universal patient positioning aid for MR and CT imaging.

Pearl Technology AG

Radiological general body-part positioner

• Primary Device ID: 07640178060319
• NIH Device Record Key: 90b3e06b-0e8c-48eb-b59e-b03471481ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PearlFit Cushion 50x20x4 Vac
• Version Model Number: PearlFit Cushion 50x20x4 Vac
• Catalog Number: 1131
• Company DUNS: 480151859
• Company Name: Pearl Technology AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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: true
• 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	07640178060319 [Primary]

FDA Product Code

• KXH: Cradle, Patient, 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: 2022-05-19
• Device Publish Date: 2022-05-11

Devices Manufactured by Pearl Technology AG

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• 07640178060999 - ProFoam: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178061002 - ProFoam: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178061019 - ProFoam: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient