MR Safety Pad 1301

GUDID 07640178062160

Positioning aid to prevent direct gantry contact in MRI

Pearl Technology AG

Radiological general body-part positioner

• Primary Device ID: 07640178062160
• NIH Device Record Key: 7ae1b5bc-9a27-4301-a04c-f03e44911bae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Safety Pad
• Version Model Number: ProFoam MR Safety Angel Pad
• Catalog Number: 1301
• Company DUNS: 480151859
• Company Name: Pearl Technology AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640178062160 [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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by Pearl Technology AG

• 07640178060753 - Multipad: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178060760 - PearlFit: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178060852 - PearlFit: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178060906 - PearlFit: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 07640178060982 - ProFoam: 2025-12-25 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient
• 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