PearlFit Cushion 22x8x1

Basic Information

• Brand Name: PearlFit Cushion 22x8x1
• Primary DI: 07640178060340
• Version / Model: PearlFit Cushion 22x8x1
• Catalog Number: 1136
• Company Name: Pearl Technology AG
• Labeler DUNS: 480151859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 1
• Public Version Date: 2022-05-19
• Public Version Status: New
• Public Device Record Key: 0517888f-49c2-4a28-906b-aa4ae73fd64c

Device Description

Universal patient positioning aid for MR and CT imaging.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXH	Cradle, Patient, Radiologic	Radiology	892.1830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61131	Radiological general body-part positioner	A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640178060340	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]