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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-0506
In Commercial Distribution

  • 09348215128951 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1955
In Commercial Distribution

  • 09348215128050 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-5286
In Commercial Distribution

  • 09348215124991 ()


  • Surgical implant template, reusable
The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.
Luminex Molecular Diagnostics, Inc
I055C0465
In Commercial Distribution

  • 00840487101872 ()
I055C0465

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Biomet Uk Ltd
32-348010
In Commercial Distribution

  • 05019279466696 ()
32-348010

  • Surgical implant template, reusable
No Description
Orthosoft Inc
20-8000-071-24
Not in Commercial Distribution

  • 00889024488502 ()

  • Length: 30 Feet


  • Robotic surgical navigation system
No Description
GLOBAL SURGICAL CORPORATION
M A730-45AV2
In Commercial Distribution

  • 00810040255441 ()


  • General-purpose surgical microscope
Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-BB Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461511 ()
SET000960-BB

  • Therapeutic oncological/gynaecological ultrasound system
Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000961 EXABLATE NEURO CLEANING KIT SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-AA Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461429 ()
SET000960-AA

  • Therapeutic oncological/gynaecological ultrasound system
Kit for single use during a Neuro V2 treatment guided under 1.5T MRI guidance. Kit content: Part Description ASC002258-CC NEURO V2 BRAIN COIL 1.5T ASSY-NON CE SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET400315-BB NEURO V2 1.5T SI COIL PATIENT ACCESSORIES SET
In Commercial Distribution

  • 07290015461535 ()
SET400315-BB

  • Therapeutic oncological/gynaecological ultrasound system
De Mayo V2®/V2E® Knee Positioner® 25" Baseplate w/Removable Carriage & Single Bar Lock Base
Innovative Medical Products, Inc
114-S BP
In Commercial Distribution

  • 00696588002453 ()
114-S BP

  • Leg procedure positioner
De Mayo V2®/V2E® Knee Positioner® 30" Baseplate w/Removable Carriage & Single Bar Lock Base
Innovative Medical Products, Inc
114-BP
In Commercial Distribution

  • 00696588002446 ()
114-BP

  • Leg procedure positioner
Ultrasonic Scalers
Guilin Woodpecker Medical Instrument Co., Ltd.
V1、V2、V2 LED、V3、V3 LED
In Commercial Distribution

  • 06944843601632 ()


  • Ultrasonic dental scaling/debridement system
Demo De Mayo V2®/V2E® Knee Positioner® 30" Baseplate w/Removable Carriage & Single Bar Lock Base
Innovative Medical Products, Inc
114-BP DEMO
In Commercial Distribution

  • 00696588005362 ()
114-BP DEMO

  • Leg procedure positioner
No Description
Roche Molecular Systems, Inc.
09049339190
In Commercial Distribution

  • 00875197006292 ()
09049339190

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-2460
In Commercial Distribution

  • 09348215129149 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1110
In Commercial Distribution

  • 09348215127541 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-5371
In Commercial Distribution

  • 09348215125035 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-5348
In Commercial Distribution

  • 09348215125028 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-5318
In Commercial Distribution

  • 09348215125011 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-5316
In Commercial Distribution

  • 09348215125004 ()


  • Surgical implant template, reusable
EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9056
Not in Commercial Distribution

  • 08806387890560 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9055
Not in Commercial Distribution

  • 08806387890553 ()


  • Endodontic obturation system
The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the NextSeq 550Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019558, NextSeq™ 550Dx Accessory Box – 300 cycles; 20019557, NextSeq™ 550Dx High Output Flow Cell Cartridge v2, 300 cycles; 20019555, NextSeq™ 550Dx, High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles.
ILLUMINA, INC.
20019554
Not in Commercial Distribution

  • 00816270020095 ()
20019554

  • Nucleic acid sequencing reagent kit IVD
MEDTRONIC FHC MICRODRIVE HOLDER (V2) instrument Rosa 3.0 mechanical holder for FHC DBS microdrive, supplied with M5 x 10 wing nut
MEDTECH
ROSA-282C
Not in Commercial Distribution

  • 03760244030108 ()
ROSAS00018

  • Neurological stereotactic surgery system
Consumable Kit (Triple Needle Cartridge,V2) includes the following items: Needle Cartridge (EL-03N02) Biofilter Suction Tube Cleaning Cover (EL-CCV01) Tube Clip (EL-CLP01)
Cytrellis Biosystems, Inc.
EL-KIT02
In Commercial Distribution

  • B933ELKIT02 ()
EL-KIT02

  • Cosmetic micro-needling electronic handpiece, professional
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v2 (w/o Gel)
In Commercial Distribution

  • 06430065790044 ()


  • Bone absorptiometric ultrasound system
ACC. ME IRIC CHARGER V2-C
Ws Audiology Usa, Inc.
MECHARGE iRIC Charger v2
In Commercial Distribution

  • 05714880213195 ()
21030566

  • Air-conduction hearing aid, receiver-in-canal
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680069 ()
  • 05060488680298 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Medium
In Commercial Distribution

  • 05060488680052 ()
  • 05060488680281 ()
Lifetemp Sensor - V2 - Medium

  • Physiological measuring device wireless data capture/transfer unit
Continuous Clinical Thermometer
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution

  • 05060488680045 ()
  • 05060488680274 ()
Lifetemp Sensor - V2 - Large

  • Physiological measuring device wireless data capture/transfer unit
Endodontic instrument for professional dental use only
MICRO MEGA
Asst v2 L21 Sterile
In Commercial Distribution

  • 23701310322769 ()
  • 03701310322765 ()
EORUA21Sv2

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professional dental use only
MICRO MEGA
Asst v2 L25 Sterile
In Commercial Distribution

  • 23701310322752 ()
  • 03701310322758 ()
EORUA25Sv2

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professional dental use only
MICRO MEGA
Asst v2 L31 Sterile
In Commercial Distribution

  • 23701310322745 ()
  • 03701310322741 ()
EORUA31Sv2

  • Rotary/reciprocating endodontic file/rasp, single-use
No Description
IMPLANET
Madison BL Base V2
In Commercial Distribution

  • 03607505404530 ()
540453

  • Orthopaedic surgical procedure kit, non-medicated, reusable
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
PC420 DARK WALNUT V2
In Commercial Distribution

  • 00045915828509 ()
PC-420-100-011

  • Bed/chair electric massager
COCAINE PLUS
UTAK LABORATORIES, INC.
COC+ U V2 MAYO
In Commercial Distribution

  • B800COCUV2MAYO5 ()
  • B800COCUV2MAYO0 ()

  • Total Volume: 20 Milliliter
COC+ U V2 MAYO

  • Multiple drugs of abuse IVD, control
AMINES LOW
UTAK LABORATORIES, INC.
AMINES H V2 CONT
In Commercial Distribution

  • B800AMINESLCONT5 ()
  • B800AMINESLCONT0 ()

  • Total Volume: 10 Milliliter
AMINES H V2 CONT

  • Multiple drugs of abuse IVD, control
AMINES HIGH
UTAK LABORATORIES, INC.
AMINES H V2 CONT
In Commercial Distribution

  • B800AMINESHV2CONT5 ()
  • B800AMINESHV2CONT0 ()

  • Total Volume: 10 Milliliter
AMINES H V2 CONT

  • Multiple drugs of abuse IVD, control
NORMAL RANGE TRACE ELEMENTS
UTAK LABORATORIES, INC.
66816 V2 NR LC
In Commercial Distribution

  • B80066816V2NRLC5 ()
  • B80066816V2NRLC0 ()

  • Total Volume: 5 Milliliter
66816 V2 NR LC

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system
CYF-V2 Flex CystoNephro Videoscope
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
Not in Commercial Distribution

  • 04953170339431 ()


  • Flexible video cystonephroscope, reusable
VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE V2
In Commercial Distribution

  • 04953170411342 ()


  • Flexible video laryngoscope
VISERA CYSTO-NEPHRO VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
In Commercial Distribution

  • 04953170411199 ()
N6005730

  • Flexible video cystonephroscope, reusable
ENF-V2 Video Rhinolaryngoscope
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE V2
Not in Commercial Distribution

  • 04953170291029 ()


  • Flexible video laryngoscope
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
Not in Commercial Distribution

  • 04953170287091 ()


  • Flexible video cystonephroscope, reusable
VOLATILES PLUS LOW
UTAK LABORATORIES, INC.
VOL+ L V2 HMC
In Commercial Distribution

  • B800VOLLV2HMC5 ()
  • B800VOLLV2HMC0 ()

  • Total Volume: 5 Milliliter
VOL+ L V2 HMC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE HIGH LEVEL 3
UTAK LABORATORIES, INC.
LEFLU HIGH L3 V2
In Commercial Distribution

  • B800LEFLUHIGHL3V25 ()
  • B800LEFLUHIGHL3V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L3 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 2
UTAK LABORATORIES, INC.
LEFLU HIGH L2 V2
In Commercial Distribution

  • B800LEFLUHIGHL2V25 ()
  • B800LEFLUHIGHL2V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L2 V2

  • Multiple drugs of abuse IVD, control
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