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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AQ CO7 MNR T, 2.4G NFM DPB MAC ACCUQ
Bernafon AG
182150
In Commercial Distribution

  • 05711584079775 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB MSIL/MAC ACCUQ
Bernafon AG
182148
In Commercial Distribution

  • 05711584079751 ()


  • Air-conduction hearing aid, receiver-in-the-ear
No Description
Giles Scientific, Inc.
V3
In Commercial Distribution

  • 00863504000217 ()
BV3

  • Antimicrobial susceptibility/resistance testing interpretive software IVD
  • Colony counter IVD, automated/semi-automated
AQ CO7 MNR T, 2.4G NFM DPB SABE/MAC ACCUQ
Bernafon AG
182135
In Commercial Distribution

  • 05711584079713 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices. Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.
DIREX SYSTEMS CORP.
COMPACT DUET
In Commercial Distribution

  • 00863499000339 ()


  • Spark-gap lithotripsy system
AQ CO9 MNR, 2.4G NFM PB ANBR ACCUQ
Bernafon AG
181960
In Commercial Distribution

  • 05711584079249 ()


  • Air-conduction hearing aid, receiver-in-the-ear
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.
DIREX SYSTEMS CORP.
INTEGRA
In Commercial Distribution

  • 00863499000315 ()


  • Electromechanical lithotripsy system, extracorporeal
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate. A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone. The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization.
DIREX SYSTEMS CORP.
MAGNA
In Commercial Distribution

  • 00863499000308 ()
10-MGNA-000

  • Electromechanical lithotripsy system, extracorporeal
AQ CO9 MNR, 2.4G NFM PB MAC/MSIL ACCUQ
Bernafon AG
181956
In Commercial Distribution

  • 05711584079201 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MSIL ACCUQ
Bernafon AG
181955
In Commercial Distribution

  • 05711584079195 ()


  • Air-conduction hearing aid, receiver-in-the-ear
LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/ml Phencyclidine (PCP) 25 ng/ml Methamphetamine (MET) 1000 ng/ml Opiate (OPI) 2000 ng/ml Barbiturates (BAR) 300 ng/ml Benzodiazepine (BZD) 300 ng/ml Marijuana (THC) 50 ng/ml Methadone (MAD) 300 ng/ml Oxycodone (OXY) 100 ng/ml Tricyclic Antidepressants (TCA) 1000 ng/ml Cocaine (COC) 300ng/ml
Lifesign L.L.C.
60B02
Not in Commercial Distribution

  • 20863480002100 ()
  • 10863480002103 ()
  • 00863480002106 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Bone Graft Delivery Device
SPINAL SURGICAL STRATEGIES
10101-S
In Commercial Distribution

  • 00863462000205 ()
10101-S

  • Bone grafting cannula
AQ CO9 MNR T, 2.4G NFM DPB MSIL/MAC ACCUQ
Bernafon AG
182143
In Commercial Distribution

  • 05711584078693 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB MAC ACCUQ
Bernafon AG
182141
In Commercial Distribution

  • 05711584078679 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB MSIL ACCUQ
Bernafon AG
182139
In Commercial Distribution

  • 05711584078655 ()


  • Air-conduction hearing aid, receiver-in-the-ear
No Description
CHIEF POWER CHAIR, LLC
Chief 107-ZRx
In Commercial Distribution

  • 00863444000308 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
AQ CO5 MNR T, 2.4G NFM DPB SABE/MAC DEMO ACCUQ
Bernafon AG
182162
In Commercial Distribution

  • 05711584078181 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR, 2.4G NFM PB SABE/MAC DEMO ACCUQ
Bernafon AG
181981
In Commercial Distribution

  • 05711584078082 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB SABE/MAC DEMO ACCUQ
Bernafon AG
181971
In Commercial Distribution

  • 05711584078075 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-3
In Commercial Distribution

  • 10863398000246 ()
  • 00863398000249 ()


  • Bioelectrical body composition analyser
AQ CO5 B 105, 2.4G NFM DPB SABE/MAC ACCUQ
Bernafon AG
182069
In Commercial Distribution

  • 05711584077818 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB JEBL ACCUQ
Bernafon AG
182067
In Commercial Distribution

  • 05711584077795 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB MSIL ACCUQ
Bernafon AG
182065
In Commercial Distribution

  • 05711584077771 ()


  • Air-conduction hearing aid, behind-the-ear
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution

  • 00863342000318 ()


  • High-efficiency filter air cleaner, mobile
AQ CO5 B 105, 2.4G NFM DPB MAC ACCUQ
Bernafon AG
182063
In Commercial Distribution

  • 05711584077757 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO7 B 105, 2.4G NFM DPB MSIL/MAC ACCUQ
Bernafon AG
182061
In Commercial Distribution

  • 05711584077283 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO7 B 105, 2.4G NFM DPB MAC ACCUQ
Bernafon AG
182060
In Commercial Distribution

  • 05711584077276 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO7 B 105, 2.4G NFM DPB SABE/MSIL ACCUQ
Bernafon AG
182059
In Commercial Distribution

  • 05711584077269 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO7 B 105, 2.4G NFM DPB MSIL ACCUQ
Bernafon AG
182058
In Commercial Distribution

  • 05711584077252 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO7 B 105, 2.4G NFM DPB COBR ACCUQ
Bernafon AG
182057
In Commercial Distribution

  • 05711584077245 ()


  • Air-conduction hearing aid, behind-the-ear
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