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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4 Panel OralTox - AMP/COC/OPI/PCP
PREMIER BIOTECH, INC
OT80404
Not in Commercial Distribution

  • B313OT804041 ()
  • B3130T804040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - COC/MET/OPI/OXY
PREMIER BIOTECH, INC
OT80402
Not in Commercial Distribution

  • B313OT804021 ()
  • B313OT804020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - AMP/COC/OPI/THC
PREMIER BIOTECH, INC
OT80401
Not in Commercial Distribution

  • B313OT804011 ()
  • B313OT804010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RFB FLAT PANEL LCD 19 NDS RADIANCE
Smith & Nephew, Inc.
72200020F
In Commercial Distribution

  • 03596010611598 ()
72200020F

  • Image display unit, colour
OPI 2000 Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114
In Commercial Distribution

  • 20817038020474 ()
  • 10817038020477 ()
  • 00817038020470 ()
U-OPI-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Bulb Holder for Kompak,Desk & Panel Wall
W. A. BAUM CO., INC.
2430
In Commercial Distribution

  • 00810010923646 ()
2430

  • Aneroid manual sphygmomanometer
PF 6840-4 TC Remote Panel 4 Channels
Perimed AB
PF 6840-4
In Commercial Distribution

  • 07332834000820 ()


  • Transcutaneous blood gas monitoring system
PF 6840-2 TC Remote Panel 2 Channels
Perimed AB
PF 6840-2
In Commercial Distribution

  • 07332834000806 ()


  • Transcutaneous blood gas monitoring system
PF 6840-1 TC Remote Panel 1 Channel
Perimed AB
PF 6840-1
In Commercial Distribution

  • 07332834000790 ()


  • Transcutaneous blood gas monitoring system
RFB MTO TOUCH PANEL LCD 19 U.S.
Smith & Nephew, Inc.
7210345F
Not in Commercial Distribution

  • 00885556610053 ()
7210345F

  • Surgical staple loading unit, non-cutting
Nylon Restraint Strap with Gel Mid Panel
David Scott Company
BD500-G
In Commercial Distribution

  • 15060797554171 ()
BD500-G

  • Medical table restraint anchor
GENESIS II PLASTIC FEMORAL TRIAL PANEL 7-8
Smith & Nephew, Inc.
71436402
In Commercial Distribution

  • 00885556626108 ()
71436402

  • Instrument tray, reusable
Sterile Labels - Custom, Liquid Medicines, 10 labels per panel, 1 panel per pouch, 100 pouches per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771052825 ()
  • 10849771052828 ()
  • 00849771052821 ()
  • 00849771035466 ()
SL113

  • Procedural medication labelling set
No Description
Clinical Guard
Drug Test Panel
In Commercial Distribution

  • 00851950008147 ()
  • 00851950008079 ()
  • 10851950008144 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
LivaNova Deutschland GmbH
Pump Control Panel
In Commercial Distribution

  • 04033817902782 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Pump Control Panel
In Commercial Distribution

  • 04033817901006 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Pump Control Panel
In Commercial Distribution

  • 04033817900986 ()


  • Cardiopulmonary bypass system, roller type
A flat panel sensor holder used to mount a 17" x 17" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER4343 E
In Commercial Distribution

  • 04547410480665 ()

  • 546.0 mm x 589.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A flat panel sensor holder used to mount a 14" x 17" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER3543 E
In Commercial Distribution

  • 04547410480658 ()

  • 546.0 mm x 513.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A flat panel sensor holder used to mount a 10" x 12" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER2530 E
In Commercial Distribution

  • 04547410480641 ()

  • 442.8 mm x 437.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 600/601 MP E
In Commercial Distribution

  • 04547410178678 ()


  • Stationary basic diagnostic x-ray system, digital
Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 900 MP W E
In Commercial Distribution

  • 04547410311631 ()


  • Stationary basic diagnostic x-ray system, digital
Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 900 MP E
In Commercial Distribution

  • 04547410306644 ()

  • 464.5 x 516.7 x 18 mm


  • Stationary basic diagnostic x-ray system, digital
Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 670 MP A E
In Commercial Distribution

  • 04547410261172 ()


  • Stationary basic diagnostic x-ray system, digital
Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 600/601 MP A E
In Commercial Distribution

  • 04547410259056 ()


  • Stationary basic diagnostic x-ray system, digital
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run. Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution

  • 00816270020088 ()
20012431

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
ATLAS Stim Headbox with High Density side panel.
NEURALYNX, INC.
High Density
In Commercial Distribution

  • 00850011306345 ()
31-0601-0132

  • Somatosensory electrical stimulation system
VIROTROL RPR Panel (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
01400
In Commercial Distribution

  • 00847661002918 ()
01400

  • Treponema pallidum reagin antibody IVD, control
COMPACT CART W/ ARM SYS. FOR FLAT PANEL
PENTAX OF AMERICA, INC.
80242
In Commercial Distribution

  • 04961333241095 ()

  • Depth: 24.6 Inch
  • Width: 24.0 Inch
  • Height: 37.5 Inch


  • Endoscope transport trolley
OEC Disposables, 31cm Flat Panel CFD OEC One
TIDI PRODUCTS, LLC
33326
In Commercial Distribution

  • 10618125190048 ()
  • 00618125190041 ()
5857958

  • Medical equipment/instrument drape, single-use
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