Home GUDID B108890POAMUS00 BTL-890U
Primary DI B108890POAMUS00
Brand BTL-890U
Company BTL INDUSTRIES LIMITED
Model BTL-890U
Published 2026-08-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories PBX Massager, Vacuum, Radio Frequency Induced Heat
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2 PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B108890POAMUS00 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multi-modality hyperthermia system A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using multiple energy sources, for the treatment of malignant or benign tumours, or other disease conditions. It includes a patient-end applicator, software, and a multi-modality generator(s)/control unit. It is intended to achieve whole-body and localized heating of tissues using two or more energy sources [e.g., ultrasound, radio-frequency (RF), microwave, circulating heated fluid] through either externally-mounted components, or from catheter- or probe-type applicators inserted endoscopically or surgically.
Regulatory Flags# DUNS number 733532951 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841019124000 Kirwan KIRWAN SURGICAL PRODUCTS LLC GEI 2026-09-19 00841019124055 Kirwan KIRWAN SURGICAL PRODUCTS LLC GEI 2026-09-19 08032625821120 GLOBUS DOMINO SRL PBX 2026-09-19 00190776429140 Millennium Avalign Technologies, Inc. GEI 2026-09-04 00840113233281 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233304 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233328 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233342 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233366 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233380 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233403 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233427 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233441 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233465 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233489 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233502 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233526 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237326 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237340 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237593 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237623 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237661 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237692 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00190776428006 Millennium Avalign Technologies, Inc. GEI 2026-08-27 00190776428037 Millennium Avalign Technologies, Inc. GEI 2026-08-27 B4193533010 Maxtown Medical Modern Surgical Instruments LLC GEI 2026-08-27 ESUMARS980010 Sutter Sutter Medizintechnik GmbH GEI 2026-08-27 00190776427436 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427542 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427573 Millennium Avalign Technologies, Inc. GEI 2026-08-26