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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RESOLVE PANEL B 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
719520
In Commercial Distribution

  • 10758750004003 ()
719520

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
RESOLVE PANEL A 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
719510
In Commercial Distribution

  • 10758750003990 ()
719510

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
16-1P3-3869
In Commercial Distribution

  • 00898142001722 ()
16-1P3-3869

  • Cranioplasty sheet
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
16-1P3-8915
In Commercial Distribution

  • 00898142001708 ()
16-1P3-8915

  • Cranioplasty sheet
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ANNUNCIATOR,REMOTE PANEL,PC6K
Crest Healthcare Supply
18B600R
In Commercial Distribution

  • B48418B600R0 ()


  • Nurse call system
THL Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN262
In Commercial Distribution

  • 00817100020339 ()


  • Diagnostic x-ray digital imaging conversion system
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-154
In Commercial Distribution

  • 20816490022729 ()
  • 10816490022722 ()
  • 00816490022725 ()
HCDOAA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-155
In Commercial Distribution

  • 20816490022248 ()
  • 10816490022241 ()
  • 00816490022244 ()
HCDOAA-155

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MMR IHC Panel Antibody
Ventana Medical Systems, Inc.
790-5091
In Commercial Distribution

  • 07613336100561 ()
07862237001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MLH1 protein IVD, antibody
Assayed Respiratory Control Panel
MICROBIOLOGICS INC.
8199 Cepheid Xpert® Respiratory Control Panel
In Commercial Distribution

  • 70845357041240 ()
8199

  • Multiple-genus respiratory virus nucleic acid IVD, control
KIT, PANEL, PL691, 5-PCS
Securitas Healthcare LLC
RP131K
In Commercial Distribution

  • 00812664024137 ()
  • 00812664023710 ()
RP131K

  • Nurse call system alarm
CardioChek Lipid Panel Test
HENRY SCHEIN, INC.
5700414
In Commercial Distribution

  • 10304040037741 ()
  • 00304040037744 ()
5700414

  • Multiple lipid analyte IVD, kit, spectrophotometry
DELTA 2.2MM PANEL 116x11x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92019
In Commercial Distribution

  • 07613252528999 ()

  • Width: 11.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92019

  • Craniofacial fixation plate, bioabsorbable
Delta 1.7mm Panel 122x122x0.75mm
Stryker Leibinger GmbH & Co. KG
70-92012
In Commercial Distribution

  • 07613252448808 ()

  • Thickness: 0.75 Millimeter
  • Length: 122.0 Millimeter
  • Width: 122.0 Millimeter
70-92012

  • Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM PANEL 116x17x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92020
In Commercial Distribution

  • 07613252529002 ()

  • Width: 17.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92020

  • Craniofacial fixation plate, bioabsorbable
ELR PANEL&HDW BLUE-PR
GF HEALTH PRODUCTS, INC.
90763132
In Commercial Distribution

  • M368907631321 ()
90763132

  • Wheelchair legrest pad
ELR PANEL&HDW BLACK-PR
GF HEALTH PRODUCTS, INC.
90763032A
In Commercial Distribution

  • M36890763032A1 ()
90763032A

  • Wheelchair legrest pad
LEGION FEMORALTRIAL PANEL 7-8
Smith & Nephew, Inc.
71442167
In Commercial Distribution

  • 00885556613511 ()
71442167

  • Instrument tray, reusable
RFBFLAT PANEL LCD 23
Smith & Nephew, Inc.
72201088F
Not in Commercial Distribution

  • 00885556571910 ()
72201088F

  • Image display unit, colour
FLAT PANEL LCD 26
Smith & Nephew, Inc.
72202591
In Commercial Distribution

  • 00885556541098 ()
72202591

  • Image display unit, colour
KIT, RETAINING, HEAD PANEL
JOERNS HEALTHCARE, LLC
N495AL
In Commercial Distribution

  • 00810055882724 ()
N495AL

  • Basic electric hospital bed
KIT, RETAINING, FOOT PANEL
JOERNS HEALTHCARE, LLC
N494AL
In Commercial Distribution

  • 00810055882717 ()
N494AL

  • Basic electric hospital bed
CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator
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