Home GUDID 14953170440028 THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm
Primary DI 14953170440028
Brand THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model TB2-0545FC
Catalog number R5001011
Published 2025-12-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14953170440028 Package GS1 1 In Commercial Distribution 04953170440021 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14953170440028 14953170440028 04953170440021 04953170440021 4953170440021
GMDN Terms# Term, Definition table Term Definition Endoscopic electrosurgical/ultrasonic surgical system instrument A hand-held, endoscopic device intended to be used as part of an electrosurgical/ultrasonic system to deliver both: 1) ultrasonic energy; and 2) bipolar electrosurgical current for fragmenting, cutting and coagulation of soft-tissues during endoscopic (e.g., laparoscopic) surgery; it may in addition be intended for open surgery. It includes a handpiece/holder with controls and a long, thin shaft with distal electrodes and an ultrasonic tip, and may include a lumen for suction/irrigation; it does not include an ultrasonic transducer. It is available in a variety of forms (e.g., forceps, rigid probe). This is a single-use device.
Regulatory Flags# DUNS number 711789789 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04953170373763 ENDOCAPSULE SOFTWARE 10 MAJ-2188 N5400340 2016-09-21 04953170373800 ENDOCAPSULE SOFTWARE 10 LIGHT MAJ-2189 N5400440 2016-09-21 04953170373848 ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE MAJ-2190 N5400540 2016-09-21 04953170360817 ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT MAJ-2038 N5368840 2023-06-21 04953170360824 ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT MAJ-2039 N5368940 2023-06-21 04953170410178 EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 N6003140 2025-11-19 04953170411939 Single Use Biopsy Forceps FB-456D FB-456D N6008330 2020-09-29 04953170424724 Infrared imaging unit MAJ-2304 N5769545 2021-05-31 04953170428142 VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR N5427045 2021-03-03 04953170054358 Brush MH-362 4116800 2016-09-21 04953170058783 BALLOON3 MAJ-233 2017-10-12 04953170058882 BALLOON3 MAJ-249 2017-10-12 04953170142628 SonoSurg Transducer SonoSurg-T2H-C 2017-10-06 04953170208485 Cleaning brush MAJ-1534 N2301000 2016-09-21 04953170234859 SonoSurg Straight Scissors,Pistol Grip,5mm x 34cm T3771 2017-10-06 04953170234880 SonoSurg Curved Scissors,Pistol Grip,5mm x 34cm T3775 2017-10-06 04953170234941 SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cm T3900 2017-10-06 04953170235030 SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cm T3915 2017-10-06 04953170235122 SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cm T3930 2017-10-06 04953170235153 SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cm T3935 2017-10-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00190776427672 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427689 Millennium Avalign Technologies, Inc. GEI 2026-08-26 B108890POAMUS00 BTL-890U BTL INDUSTRIES LIMITED GEI 2026-08-26
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