XP 2 applicator

Basic Information

• Brand Name: XP 2 applicator
• Primary DI: B108215APSAPWRE1000
• Version / Model: 215-7
• Company Name: BTL INDUSTRIES LIMITED
• Labeler DUNS: 733532951
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dd2d00c4-a89b-4d02-b8b9-c69b22efb0fe

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40737	Hyperthermia system gantry	An integral component of a therapeutic hyperthermia system that typically consists of a stationary stand or frame stabilized by side supports that acts as the primary support and housing for the non-ionizing radiation generating components or assemblies, e.g., ultrasound or radio-frequency (RF), motors and related electronics of a therapeutic hyperthermia configuration. Some hyperthermia gantry designs can incorporate a motorized table for patient support and positioning during treatment. Depending on the design, it can include a variety of other components, e.g., motors, mounts or motion controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B108215APSAPWRE1000	HIBCC