Aquaplast RT™

Basic Information

• Brand Name: Aquaplast RT™
• Primary DI: 10841962104101
• Version / Model: RT-1908-4
• Catalog Number: RT-1908-4
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-12-22
• Public Version: 5
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 5d84daa5-7fd9-4075-8c7d-d4686d67bca8

Device Description

Aquaplast RT Custom Bolus, 4.8mm, 7cm x 22cm

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58021	Radiation therapy bolus, single-use	A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841962104101	GS1
Unit of Use	10841962104118	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	22	Centimeter
Depth	4.8	Millimeter
Length	7	Centimeter