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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Vascular Table with Fowler Backrest, Standard; 30" Width; 240V Electric Ultrasound (EA) Ergonomics Advantage Series
OAKWORKS, INC.
EA Vascular Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025569 ()


  • Examination/treatment table, line-powered
Vascular Ergonomic Advantage Table with Fowler Backrest, Standard; 26" Width; 120V Electric
OAKWORKS, INC.
Vascular EA Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025552 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Right Back Support; 30" Width; 120V Electric
OAKWORKS, INC.
Vascular Table EA with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025545 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Right and Left Back Supports; 30" Width; 120V Electric
OAKWORKS, INC.
Vascular EA Table with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025538 ()


  • Examination/treatment table, line-powered
Vascular Table with Fowler Backrest, Cardio with Right back Support; 30" Width; 120V Electric
OAKWORKS, INC.
Vascular Table EA with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025521 ()


  • Examination/treatment table, line-powered
Backrest, Standard; 30" Width; 120V Electric
OAKWORKS, INC.
Vascular Table EA with Fowler (V2 Model)
In Commercial Distribution

  • 00817463025514 ()


  • Examination/treatment table, line-powered
Adapter Set for Olympus EUS Radial Each Set Consists of: (1) WATER JET ADAPTER V2 (1) AIR WATER/SUCTION FLOW (1) SUCTION PLUG (1) BIOPSY PORT PLUG (1) LL-MTF CONNECTOR - Female Luer Lock to Male Luer Lock (2.5") TS- Tubing Soft - 1 Set / 100 Sets per Case
CYGNUS MEDICAL L.L.C.
ASO6E
In Commercial Distribution

  • 10843356101208 ()
  • 00843356101201 ()


  • Endoscope dryer
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.
ILLUMINA, INC.
20028870
In Commercial Distribution

  • 00816270020132 ()
20028870

  • Nucleic acid sequencing reagent kit IVD
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is a single-use set of reagents and consumables for sequencing on the NextSeq™ 550Dx instrument. For its input, the NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) uses libraries generated from DNA where sample indexes and capture sequences are added to amplified targets. Sample 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 fluorescently-labeled single nucleotide bases as they are incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019555, NextSeq™ 550Dx High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles; 20026365, NextSeq™ 550Dx High Output Flow Cell Cartridge v2.5, 300 cycles; 20019558, NextSeq™ 550Dx Accessory Box – 300 cycles.
ILLUMINA, INC.
20028871
In Commercial Distribution

  • 00816270020118 ()
20028871

  • Nucleic acid sequencing reagent kit IVD
MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.
MindMaze SA
MMG-01
In Commercial Distribution

  • 03760272650019 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101315-E QScreen Check Kit P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
PATH medical GmbH
101275-AS-HP
In Commercial Distribution

  • 04260223147302 ()


  • Evoked-potential audiometer
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101315-E QScreen Check Kit P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
PATH medical GmbH
101275-A-HP
In Commercial Distribution

  • 04260223146534 ()


  • Evoked-potential audiometer
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100110-QScreen FW DPOAE P/N 100536-QScreen FW FMDPOAE P/N 100414-QScreen FW Labelprinter P/N 101043 Accessory box EP-LT (AB-LT01) P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual English
PATH medical GmbH
101275-D-A-HP
In Commercial Distribution

  • 04260223146558 ()


  • Evoked-potential audiometer
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100109-QScreen FW TEOAE P/N 100414-QScreen FW Labelprinter P/N 101043 Accessory box EP-LT (AB-LT01) P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual English
PATH medical GmbH
101275-T-A-HP
In Commercial Distribution

  • 04260223146541 ()


  • Evoked-potential audiometer
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD65 v2 P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100110-QScreen FW DPOAE P/N 100536-QScreen FW FMDPOAE P/N 100109-QScreen FW TEOAE P/N 100414-QScreen FW Labelprinter P/N 101043 Accessory box EP-LT (AB-LT01) P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual English
PATH medical GmbH
101275-T-D-A-HP
In Commercial Distribution

  • 04260223146565 ()


  • Evoked-potential audiometer
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