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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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SPO2 AD CB, NELCR to SPLABS, ULTRAVIEW8
CURBELL MEDICAL PRODUCTS, INC.
CB-A400-1103A
In Commercial Distribution

  • 00840828146609 ()
5587

  • Electrical-only medical device connection cable, reusable
5-LD ECG CABLE DATEX TO GE LEADS
CURBELL MEDICAL PRODUCTS, INC.
CB-51595R
In Commercial Distribution

  • 00840828146029 ()
5463

  • Electrocardiographic electrode connector
5-LD TWIN TO 001A ECG CABLE, A
CURBELL MEDICAL PRODUCTS, INC.
CB-81540R
In Commercial Distribution

  • 00840828146005 ()
5550

  • Electrocardiographic electrode connector
6ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
RF-T15
In Commercial Distribution

  • 10816203020205 ()
  • 20816203020202 ()


  • Blood transfer set
Contoured wide range Blood Pressure Cuff 9" to 17"
Omron Healthcare, Inc.
CD-WR17
In Commercial Distribution

  • 00073796343170 ()
  • 10073796343177 ()
CD-WR17

  • Blood pressure cuff, reusable
Stainless steel bar-code (to attach), 10 units
PLASMABIOTICS
CBar-IN
In Commercial Distribution

  • 03701354404809 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
No Description
Roche Diagnostics GmbH
5401674190
In Commercial Distribution

  • 04015630926961 ()
5401674190

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
No Description
CEDIC SRL
A555
In Commercial Distribution

  • 08056093720709 ()
  • 08056093720693 ()
  • 08056093720686 ()


  • Enteral feeding/medication connector, non-sterile
No Description
Dynarex Corporation
10746XL
In Commercial Distribution

  • 00840117300316 ()
  • 00616784074641 ()


  • Solid-seat mobile patient lifting system seat
No Description
Dynarex Corporation
10746LG
In Commercial Distribution

  • 00840117300309 ()
  • 00616784074634 ()


  • Solid-seat mobile patient lifting system seat
JUMPER,120",P103 TO RJ12
CURBELL MEDICAL PRODUCTS, INC.
JU96-811
In Commercial Distribution

  • 00840828195355 ()
30364

  • Electrical mains power extension cable
Adapter, Syringe to NDD Syringe Adapter 5030-2
A-M SYSTEMS, LLC
Adapter, Syringe to NDD Syringe Adapter 5030-2
In Commercial Distribution

  • 00817081027242 ()
  • 00817081027235 ()
115614

  • High-pressure medical gas hose
Small Adapter, VBMAX35 to Collins Pulmonary Function Testing Machines
A-M SYSTEMS, LLC
Adapter, VBMax35 to Collins Mach. - 115523
In Commercial Distribution

  • 00817081023060 ()
  • 00817081023053 ()
115523

  • Breathing mouthpiece, reusable
No Description
Roche Diagnostics GmbH
08057958190
In Commercial Distribution

  • 07613336121368 ()
08057958190

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
08056757190
In Commercial Distribution

  • 07613336120972 ()
08056757190

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
No Description
SURETEK MEDICAL
P9357
In Commercial Distribution

  • B390P93571 ()


  • Arthroscopic shaver system blade, reprocessed
Fenestrated grasp.fcps.insert,5/330mm compatible to Storz
mahe medical gmbh
018.33S
In Commercial Distribution

  • EMAH01833S1 ()
  • EMAH01833S0 ()
018.33S

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Maryland grasp.fcps.insert ,5/330mm compatible to Storz
mahe medical gmbh
010.33S
In Commercial Distribution

  • EMAH01033S1 ()
  • EMAH01033S0 ()
010.33S

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
No Description
GLOBAL SURGICAL CORPORATION
M 713GU
In Commercial Distribution

  • 00810040251436 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-NEX
In Commercial Distribution

  • 00810040251009 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-F
In Commercial Distribution

  • 00810040250996 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-EOS
In Commercial Distribution

  • 00810040250989 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M A730-GCK
In Commercial Distribution

  • 00810040250767 ()


  • General-purpose surgical microscope
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-F to 40AES-A
In Commercial Distribution

  • 07290109142920 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40ST
In Commercial Distribution

  • 07290109142913 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40F
Not in Commercial Distribution

  • 07290109142906 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144078
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40AES-R
Not in Commercial Distribution

  • 07290109142890 ()
  • 07290109144122 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144122
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40AES-A
In Commercial Distribution

  • 07290109142883 ()
  • 07290109144078 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 30 to 30ST
In Commercial Distribution

  • 07290109142876 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-R To 40AES-A
In Commercial Distribution

  • 07290109142852 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144047; 07290109144078; 07290109144122
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-F to 40AES-R
Not in Commercial Distribution

  • 07290109142845 ()
  • 07290109144061 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
goat antiserum to human IgD
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761270 ()
127002

  • Total immunoglobulin D (IgD total) IVD, antibody
Goat antiserum to Human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761030 ()
103002

  • Total immunoglobulin M (IgM total) IVD, antibody
Goat antiserum to Human IgA
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761020 ()
102002

  • Total immunoglobulin A (IgA total) IVD, antibody
Goat antiserum to Human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761010 ()
101002

  • Total immunoglobulin G (IgG total) IVD, control
Goat antiserum to Human Alpha 1 Acid Glycoprotein
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761230 ()
123002

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent
Goat antiserum to Human C-3b Inactivator (factor I)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761210 ()
121002

  • Complement reagent IVD
Goat antiserum to Human Kappa
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761170 ()
117002

  • Kappa/lambda light chain immunoglobulin IVD, antibody
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761160 ()
116002

  • Total immunoglobulin G (IgG total) IVD, control
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592A
In Commercial Distribution

  • B1408592A0 ()

  • Length: 48 Inch
8592A

  • Pneumograph
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