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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THERAPEUTIC MONITORING PANEL
UTAK LABORATORIES, INC.
TDM U BTL
In Commercial Distribution

  • B800TDMUBTL5 ()
  • B800TDMUBTL0 ()

  • Total Volume: 5 Milliliter
TDM U BTL

  • Multiple-type clinical chemistry analyte profile IVD, control
Panel Forming Pliers
Kinamed, Inc.
14-1T1-0240
In Commercial Distribution

  • 00818720010625 ()
14-1T1-0240

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Plate/Panel Cutters
Kinamed, Inc.
14-1T1-0200
In Commercial Distribution

  • 00818720010601 ()
14-1T1-0200

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Vaginitis Validation Panel
MICROBIOLOGICS INC.
VV-01
In Commercial Distribution

  • 10634853001418 ()
VV-01

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Vaginitis Calibration Panel
MICROBIOLOGICS INC.
CV-01
In Commercial Distribution

  • 10634853001364 ()
CV-01

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, calibrator
HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HHV-6B Verification Panel
EXACT DIAGNOSTICS, LLC
HV6BP100
In Commercial Distribution

  • 00812242030383 ()
HV6BP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
HHV-6A Verification Panel
EXACT DIAGNOSTICS, LLC
HV6AP100
In Commercial Distribution

  • 00812242030376 ()
HV6AP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
VZV Verification Panel
EXACT DIAGNOSTICS, LLC
VZVP100
In Commercial Distribution

  • 00812242030345 ()
VZVP100

  • Varicella-zoster virus (VZV) nucleic acid IVD, calibrator
Adenovirus Verification Panel
EXACT DIAGNOSTICS, LLC
ADVP100
In Commercial Distribution

  • 00812242030314 ()
ADVP100

  • Adenovirus nucleic acid IVD, calibrator
Zika Verification Panel
EXACT DIAGNOSTICS, LLC
ZKVP100
In Commercial Distribution

  • 00812242030284 ()
ZKVP100

  • Zika virus nucleic acid IVD, calibrator
BKV Verification Panel
EXACT DIAGNOSTICS, LLC
BKVP100
In Commercial Distribution

  • 00812242030178 ()
BKVP100

  • BK virus (BKV) nucleic acid IVD, calibrator
EBV Verification Panel
EXACT DIAGNOSTICS, LLC
EBVP100
In Commercial Distribution

  • 00812242030147 ()
EBVP100

  • Epstein-Barr virus (EBV) nucleic acid IVD, calibrator
HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator
HPV Verification Panel
EXACT DIAGNOSTICS, LLC
HPVP200
In Commercial Distribution

  • 00812242031007 ()
HPVP200

  • Human papillomavirus (HPV) nucleic acid IVD, control
MRSA Verification Panel
EXACT DIAGNOSTICS, LLC
MRSAP200
In Commercial Distribution

  • 00812242030727 ()
MRSAP200

  • MRSA/MSSA nucleic acid IVD, control
HSV Verification Panel
EXACT DIAGNOSTICS, LLC
HSVP200
In Commercial Distribution

  • 00812242030710 ()
HSVP200

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
JCV Verification Panel
EXACT DIAGNOSTICS, LLC
JCVP100
In Commercial Distribution

  • 00812242030529 ()
JCVP100

  • JC virus (JCV) nucleic acid IVD, calibrator
HCV Verification Panel
EXACT DIAGNOSTICS, LLC
HCVP100
In Commercial Distribution

  • 00812242030086 ()
HCVP100

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator
PANEL CLAMP - LOWER
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-0640-014-00
Not in Commercial Distribution

  • 00889024367975 ()
00-0640-014-00

  • Bed traction frame
PANEL CLAMP - UPPER
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-0640-013-00
Not in Commercial Distribution

  • 00889024367968 ()
00-0640-013-00

  • Bed traction frame
SPINOMED ANTERIOR PANEL
MEDI MANUFACTURING, INC.
SL11321
In Commercial Distribution

  • 00636257038116 ()


  • Cervicothoracic spine orthosis
Control Panel Unit
NIHON KOHDEN CORPORATION
PV-230B
In Commercial Distribution

  • 04931921104002 ()
PV-230B

  • Evoked-potential graphic recording system
Deluxe Perception Panel
G&J Electronics Inc
PP-02
In Commercial Distribution

  • 00627843670926 ()


  • Gastrointestinal barostat
Control Panel Unit
NIHON KOHDEN AMERICA, INC.
PV-230B
In Commercial Distribution

  • 00841983101090 ()
PV-230B

  • Evoked-potential graphic recording system
E600 Built-In Panel
Beyes Dental Canada Inc
MT600TP
In Commercial Distribution

  • 00990010301771 ()
M600

  • Dental surgical power tool motorized handpiece/set, electric
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-3867
In Commercial Distribution

  • 00898142001944 ()
16-1P3-3867

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-9013
In Commercial Distribution

  • 00898142001746 ()
16-1P3-9013

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-4066
In Commercial Distribution

  • 00898142001739 ()
16-1P3-4066

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-8913
In Commercial Distribution

  • 00898142001692 ()
16-1P3-8913

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
14-1P3-8620
In Commercial Distribution

  • 00898142001166 ()
14-1P3-8620

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
14-1P3-8613
In Commercial Distribution

  • 00898142001135 ()
14-1P3-8613

  • Cranioplasty sheet
Triage Cardio2 Panel
QUIDEL CARDIOVASCULAR INC.
97500EU
In Commercial Distribution

  • 30014613337973 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardio3 Panel
QUIDEL CARDIOVASCULAR INC.
97400EU
In Commercial Distribution

  • 30014613337966 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel
QUIDEL CARDIOVASCULAR INC.
97000HS
In Commercial Distribution

  • 30014613337911 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Thyrpoid Panel Kit
AERO-MED, LLC
AMM4950
In Commercial Distribution

  • 00810010893048 ()
AMM4950

  • Phlebotomy kit
Panel Phoenix NMIC-305
BECTON, DICKINSON AND COMPANY
449294
Not in Commercial Distribution

  • 00382904492946 ()
  • 30382904492947 ()
449294

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix NMIC-308
BECTON, DICKINSON AND COMPANY
449065
Not in Commercial Distribution

  • 00382904490652 ()
  • 30382904490653 ()
449065

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix PMIC-110
BECTON, DICKINSON AND COMPANY
449036
In Commercial Distribution

  • 00382904490362 ()
  • 30382904490363 ()
449036

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan HNID Panel
Beckman Coulter, Inc.
B1012-10B
In Commercial Distribution

  • 15099590655402 ()
  • 05099590655405 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
PANEL DRAPE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426009829 ()
  • 30748426009825 ()
  • 00748426009824 ()


  • Patient surgical drape, single-use
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2720
In Commercial Distribution

  • 00749756569514 ()
UAP2720

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2620
In Commercial Distribution

  • 00749756569507 ()
UAP2620

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2520
In Commercial Distribution

  • 00749756569491 ()
UAP2520

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2420
In Commercial Distribution

  • 00749756569484 ()
UAP2420

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2320
In Commercial Distribution

  • 00749756569477 ()
UAP2320

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2610
In Commercial Distribution

  • 00749756569453 ()
UAP2610

  • Lumbar spine orthosis
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