pearltec 1276

GUDID 07640178062078

Positioning aid for infants (5-9kg) during MRI and CT.

Pearl Technology AG

Radiological general body-part positioner

• Primary Device ID: 07640178062078
• NIH Device Record Key: a2cdde29-826e-444a-b286-77b1fc5eb752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pearltec
• Version Model Number: BabyFix XL
• Catalog Number: 1276
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640178062078 [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

On-Brand Devices [pearltec]

• 07640178062177: Short-term patient positioning and stabilization device during invasive and non-invasive procedu
• 07640178062078: Positioning aid for infants (5-9kg) during MRI and CT.
• 07640178061811: Patient positioning aid for MR and CT imaging.