PearlFit Wedge 26x25x7 Vac 1128

GUDID 07640178060289

Universal patient positioning aid for MR and CT imaging.

Pearl Technology AG

Radiological general body-part positioner

• Primary Device ID: 07640178060289
• NIH Device Record Key: cbabdbbf-fa7c-488a-b4f8-1009bf82eff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PearlFit Wedge 26x25x7 Vac
• Version Model Number: PearlFit Wedge 26x25x7 Vac
• Catalog Number: 1128
• 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: 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	07640178060289 [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

• 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.
• 07640178060043 - Multipad Plus: 2022-05-19 Universal patient positioning aid for MR and CT imaging.
• 07640178060050 - Multipad Slim: 2022-05-19 Universal patient positioning aid for MR and CT imaging.
• 07640178060074 - Multipad Ear: 2022-05-19 Universal patient positioning aid for MR and CT imaging.
• 07640178060081 - CT HeadFix: 2022-05-19 Positioning aid for head fixation in the CT head holder.