PearlFit 5005

GUDID 07640178060760

Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient’s skin. Non-Sterile and not to be used in the sterile field.

Pearl Technology AG

Radiological general body-part positioner

• Primary Device ID: 07640178060760
• NIH Device Record Key: 43697385-174d-4fc8-9559-5bf05b44923b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PearlFit
• Version Model Number: PearlFit Forehead Kit
• Catalog Number: 5005
• 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	07640178060760 [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: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [PearlFit]

• 07640178060906: Short-term patient positioning and stabilization device during invasive and non-invasive procedu
• 07640178060852: Short-term patient positioning and stabilization device during invasive and non-invasive procedu
• 07640178060760: Short-term patient positioning and stabilization device during invasive and non-invasive procedu