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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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
Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
KIT, PANEL, PL691, 5-PCS
Securitas Healthcare LLC
RP131K
In Commercial Distribution

  • 00812664024137 ()
  • 00812664023710 ()
RP131K

  • Nurse call system alarm
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
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
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
Charging unit operating panel
Baxter Medical Systems GmbH + Co. KG
4544149
Not in Commercial Distribution

  • 00887761973732 ()


  • Operating room equipment remote control
Panel Phoenix NMIC/ID-308
BECTON, DICKINSON AND COMPANY
449282
Not in Commercial Distribution

  • 00382904492823 ()
  • 30382904492824 ()
449282

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Nmic 300
BECTON, DICKINSON AND COMPANY
448871
Not in Commercial Distribution

  • 30382904488711 ()
  • 00382904488710 ()
448871

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Nmic 303
BECTON, DICKINSON AND COMPANY
448487
Not in Commercial Distribution

  • 30382904484874 ()
  • 00382904484873 ()
448487

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic 109
BECTON, DICKINSON AND COMPANY
448419
Not in Commercial Distribution

  • 30382904484195 ()
  • 00382904484194 ()
448419

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic 107
BECTON, DICKINSON AND COMPANY
448417
In Commercial Distribution

  • 30382904484171 ()
  • 00382904484170 ()
448417

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
D-Series Panel Pad, Right
SCHUERCH CORPORATION
508-0100
In Commercial Distribution

  • 01810014600214 ()
  • 00810014600215 ()
508-0100

  • Soft-rubber chair cushion
D-Series Panel Pad, Left
SCHUERCH CORPORATION
508-0099
In Commercial Distribution

  • 00810014600208 ()
508-0099

  • Soft-rubber chair cushion
Triage Cardiac Panel (TnI)
QUIDEL CARDIOVASCULAR INC.
97021HS
In Commercial Distribution

  • 30014613337935 ()
97021HS

  • Troponin I IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Liver Enzyme Panel Kit
AERO-MED, LLC
AMM4350
In Commercial Distribution

  • 00810010893055 ()
AMM4350

  • Phlebotomy kit
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
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
LEGION FEMORALTRIAL PANEL 7-8
Smith & Nephew, Inc.
71442167
In Commercial Distribution

  • 00885556613511 ()
71442167

  • Instrument tray, reusable
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1302
In Commercial Distribution

  • 00749756569590 ()
UPP1302

  • Lumbar spine orthosis
Mano4343X Flat Panel Detector
iRay Group
Mano4343X
In Commercial Distribution

  • 06970569090443 ()


  • Indirect flat panel x-ray detector
Mano4343T Flat Panel Detector
iRay Group
Mano4343T
In Commercial Distribution

  • 06970569090436 ()


  • Indirect flat panel x-ray detector
Venu1717X Flat Panel Detector
iRay Group
Venu1717X
In Commercial Distribution

  • 06970569090429 ()


  • Indirect flat panel x-ray detector
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2302
In Commercial Distribution

  • 00749756569712 ()
UPP2302

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2701
In Commercial Distribution

  • 00749756569705 ()
UPP2701

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2601
In Commercial Distribution

  • 00749756569699 ()
UPP2601

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2401
In Commercial Distribution

  • 00749756569668 ()
UPP2401

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2301
In Commercial Distribution

  • 00749756569651 ()
UPP2301

  • Lumbar spine orthosis
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1402
In Commercial Distribution

  • 00749756569606 ()
UPP1402

  • Lumbar spine orthosis
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0110
In Commercial Distribution

  • 00858293006809 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0108
In Commercial Distribution

  • 00858293006793 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0106
In Commercial Distribution

  • 00858293006786 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0105
In Commercial Distribution

  • 00858293006779 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0204
In Commercial Distribution

  • 10858293006769 ()
  • 00858293006762 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0203
In Commercial Distribution

  • 10858293006752 ()
  • 00858293006755 ()


  • Haemodialysis dialysate central supply system
SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.
Restec Solutions LLC
0002
In Commercial Distribution

  • 00860009496903 ()
SONO-0002

  • Atomized-chemical device disinfector
High Level Disinfection System
NANOSONICS LIMITED
N05000-1
In Commercial Distribution

  • 09350855000184 ()
  • 09350855000191 ()


  • Atomized-chemical device disinfector
Trophon US Refurbished
NANOSONICS LIMITED
N00010-US-RFB
In Commercial Distribution

  • 09350855000139 ()
  • 09350855000122 ()


  • Atomized-chemical device disinfector
Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
NANOSONICS LIMITED
N00010-NNA
In Commercial Distribution

  • 09350855000115 ()
  • 09350855000016 ()


  • Atomized-chemical device disinfector
Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
NANOSONICS LIMITED
N00010-US
In Commercial Distribution

  • 09350855000108 ()
  • 09350855000009 ()


  • Atomized-chemical device disinfector
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