FDA.reportPublic FDA data

XP applicator

Primary DI
B108215APSAPWRTENUS0
Brand
XP applicator
Company
BTL INDUSTRIES LIMITED
Model
215/3
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108215APSAPWRTENUS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hyperthermia system gantryAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
733532951
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108785APMMUS10EMFACE controllerBTL-785-72023-06-28
B108699PO3M2MUS00BTL-699 EXOMINDBTL-699 EXOMIND2025-04-04
B108699BELTMEU00BeltBelt2024-11-06
B108699HEADRESTMEU00HeadrestHeadrest2024-11-06
B108699APM2MUS00EXOMIND applicatorBTL-699-AP-M-22024-08-28
B108699PO2M2MUS00EXOMINDEXOMIND2024-08-28
B108043PO30WMUS00LS-6000LS-60002024-03-22
B108451POSCAEL2MUS00Scanning System for LS-6000Scanning System for LS-60002024-03-22
B108A299AP13ENUS1020BTL Chair ApplicatorBTL Chair Applicator2019-02-25
B108D099PO130ENUS1030BTL EMSELLABTL EMSELLA2019-02-25
B108899AP2C2MUS20Small applicator899-AP-C-22023-12-08
B108899AP2C45MUS10Edge applicatorEdge applicator2023-12-08
B108899APC1ENUS0140Large applicator899-AP-C-12023-12-08
B108899PO11C1ENUS0140EMSCULPT NEOEMSCULPT NEO2023-12-08
B108785PO8MUS00BTL-785FBTL-785F2023-12-01
B108785PO9MUS00BTL-785FBTL-785F2023-12-01

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Primary DI, Brand, Company table
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