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
Biomet Orthopedics, LLC
RD180010
In Commercial Distribution

  • 00880304149762 ()

  • 55 MM
RD180010

  • Uncoated knee femur prosthesis, metallic
De Mayo V2® Knee Positioner® for Lab use only (30" Base and Boot w/Clamp Base & 114-CL)
Innovative Medical Products, Inc
114-LAB KIT
In Commercial Distribution

  • 00696588005430 ()
114-LAB KIT

  • Leg procedure positioner
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)
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
No Description
GLOBAL SURGICAL CORPORATION
M A730-45AV2
In Commercial Distribution

  • 00810040255441 ()


  • General-purpose surgical microscope
No Description
Orthosoft Inc
20-8000-071-24
Not in Commercial Distribution

  • 00889024488502 ()

  • Length: 30 Feet


  • Robotic surgical navigation 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)
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
EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD
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
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