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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Turbine
MK-Dent GmbH
PRIME LINE
In Commercial Distribution

  • E490HC8021K1 ()
HC8021K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC22KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC22K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC21KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC21K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC20KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC20K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB23KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB23K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB21KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB21K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB16L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB15L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB14

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB12

  • Dental power tool handpiece motorless component
No Description
LIVANOVA USA, INC.
Drain Line
In Commercial Distribution

  • 10803622132152 ()
  • 00803622132155 ()


  • Autotransfusion system blood component processing set
Bite Block, O2-CO2 monitoring and oxygen delivery, with strap
KEY SURGICAL, INC.
EN-315
Not in Commercial Distribution

  • 00849771043843 ()
  • 00849771037200 ()
EN315

  • Endoscopic bite block, oxygenating
No Description
BIOTRONIK SE & Co. KG
Smart 3G
In Commercial Distribution

  • 04035479139360 ()
401831

  • Patient monitoring modem
No Description
Merit Medical Systems, Inc.
10884450122782
In Commercial Distribution

  • 20884450122789 ()
  • 10884450122782 ()
  • 00884450122785 ()

  • Blade Length-110 mm
TIO60-110

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122775
In Commercial Distribution

  • 20884450122772 ()
  • 10884450122775 ()
  • 00884450122778 ()

  • Blade Length-100 mm
TIO60-100

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122768
In Commercial Distribution

  • 20884450122765 ()
  • 10884450122768 ()
  • 00884450122761 ()

  • Blade Length-90 mm
TIO60-90

  • Endoscopic bite block, oxygenating
LATITUDE ® Communicator
BOSTON SCIENTIFIC CORPORATION
6482
In Commercial Distribution

  • 00802526580802 ()


  • Patient monitoring modem
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526580727 ()


  • Patient monitoring modem
Arterial Blood Collection Kit, 48", 6cc, w/o DPT
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719026351 ()
  • H6719026350 ()

  • Total Volume: 6 Milliliter
  • Length: 48 Inch
902-635

  • Vascular catheter flush valve, continuous
  • In-line arterial blood sampling set
Arterial Blood Collection Kit w/o Transducer
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719026271 ()
  • H6719026270 ()
902-627

  • Vascular catheter flush valve, continuous
  • In-line arterial blood sampling set
50` Neonatal Circuit, Temp port, Prox line, Drop line, Neo
WESTMED, INC.
N6205CKT
In Commercial Distribution

  • 10709078002943 ()
  • 00709078002946 ()


  • Anaesthesia breathing circuit, single-use
Dual Catheter Kit: 10'' Saturation catheter
Rex Pj Tech LLC
YK10
In Commercial Distribution

  • 10857362007317 ()
  • 00857362007310 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 10'' Saturation catheter
Rex Pj Tech LLC
SK10
In Commercial Distribution

  • 10857362007300 ()
  • 00857362007303 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 5'' Saturation catheter with 6'' split sheath introducer
Rex Pj Tech LLC
YK8
In Commercial Distribution

  • 10857362007294 ()
  • 00857362007297 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 5'' Saturation catheter with 6'' split sheath introducer
Rex Pj Tech LLC
SK8
In Commercial Distribution

  • 10857362007287 ()
  • 00857362007280 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 2.5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK6
In Commercial Distribution

  • 10857362007270 ()
  • 00857362007273 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 2.5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK6
In Commercial Distribution

  • 10857362007263 ()
  • 00857362007266 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK5
In Commercial Distribution

  • 10857362007256 ()
  • 00857362007259 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK5
In Commercial Distribution

  • 10857362007249 ()
  • 00857362007242 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK2
In Commercial Distribution

  • 10857362007232 ()
  • 00857362007235 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK2
In Commercial Distribution

  • 10857362007225 ()
  • 00857362007228 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (250.0 ml/hr)
Rex Pj Tech LLC
BL1D250
In Commercial Distribution

  • 10857362007157 ()
  • 00857362007150 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (200.0 ml/hr)
Rex Pj Tech LLC
BL1D200
In Commercial Distribution

  • 10857362007140 ()
  • 00857362007143 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (50.0 ml/hr)
Rex Pj Tech LLC
BL1D050
In Commercial Distribution

  • 10857362007126 ()
  • 00857362007129 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (8.0 ml/hr)
Rex Pj Tech LLC
BL1D008
In Commercial Distribution

  • 10857362007089 ()
  • 00857362007082 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (4.0 ml/hr)
Rex Pj Tech LLC
BL1D004
In Commercial Distribution

  • 10857362007065 ()
  • 00857362007068 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (1.5 ml/hr)
Rex Pj Tech LLC
BL1D01/5
In Commercial Distribution

  • 10857362007041 ()
  • 00857362007044 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (100.0 ml/hr)
Rex Pj Tech LLC
BL1D100
In Commercial Distribution

  • 10857362007133 ()
  • 00857362007136 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (10.0 ml/hr)
Rex Pj Tech LLC
BL1D010
In Commercial Distribution

  • 10857362007119 ()
  • 00857362007112 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (5.0 ml/hr)
Rex Pj Tech LLC
BL1D005
In Commercial Distribution

  • 10857362007072 ()
  • 00857362007075 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (2.0 ml/hr)
Rex Pj Tech LLC
BL1D002
In Commercial Distribution

  • 10857362007058 ()
  • 00857362007051 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (0.8 ml/hr)
Rex Pj Tech LLC
BL1D00/8
In Commercial Distribution

  • 10857362007034 ()
  • 00857362007037 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (0.6 ml/hr)
Rex Pj Tech LLC
BL1D00/6
In Commercial Distribution

  • 10857362007027 ()
  • 00857362007020 ()


  • Prefilled mechanical infusion pump/catheter
Infuser – 275 mL Reservoir 275 mL Disposable Infusion Pump
Rex Pj Tech LLC
BL2N00
In Commercial Distribution

  • 00857362007013 ()
  • 10857362007010 ()


  • Prefilled mechanical infusion pump/catheter
Infuser – 110 mL Reservoir 100 ml Disposable Infusion Pump
Rex Pj Tech LLC
BL1N00
In Commercial Distribution

  • 00857362007006 ()
  • 10857362007003 ()


  • Prefilled mechanical infusion pump/catheter
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