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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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SIGNASPRAY - 10855683006569

SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP 50ML BOTTLE
PARKER LABORATORIES INC
ELECTRODE SOLUTION AND SKIN PREP
In Commercial Distribution

  • 10855683006569 ()
  • 00855683006562 ()
18-50

  • Electrode conductive medium

Ultradrape - 10855683006545

Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8''
PARKER LABORATORIES INC
34-15
In Commercial Distribution

  • 20855683006542 ()
  • 10855683006545 ()
  • 00855683006548 ()


  • Electrode conductive medium

REDUX - 10855683006408

Redux Electrolyte Paste, 5 oz.Tube
PARKER LABORATORIES INC
ELECTROLYTE PASTE
In Commercial Distribution

  • 10855683006408 ()
  • 00855683006401 ()
  • 20855683006405 ()
67-05

  • Electrode conductive medium

REDUX - 10855683006392

Redux Electrolyte Crème, 4 oz. Tube
PARKER LABORATORIES INC
ELECTROLYTE CREME
In Commercial Distribution

  • 10855683006392 ()
  • 00855683006395 ()
  • 20855683006399 ()
66-04

  • Electrode conductive medium

REDUX - 10855683006385

Redux Electrolyte Gel, 4 oz tube
PARKER LABORATORIES INC
ELECTROLYTE GEL
In Commercial Distribution

  • 10855683006385 ()
  • 00855683006388 ()
  • 20855683006382 ()
65-04

  • Electrode conductive medium

TENSIVE - 10855683006330

Tensive Conductive Adhesive Gel, 50 gram tube
PARKER LABORATORIES INC
CONDUCTIVE ADHESIVE GEL
In Commercial Distribution

  • 10855683006330 ()
  • 00855683006333 ()
  • 20855683006337 ()
22-60

  • Electrode conductive medium

Rochester - 10816843022683

ROCHESTER ELECTRODE JELLY: ORIGINAL SALT JELLY FORMULA
ROCHESTER ELECTRO-MEDICAL, INC.
701507-F
Not in Commercial Distribution

  • 10816843022683 ()


  • Electrode conductive medium

Rochester - 10816843022669

ROCHESTER ELECTRODE JELLY: ORIGINAL SALT JELLY FORMULA
ROCHESTER ELECTRO-MEDICAL, INC.
701505-P
Not in Commercial Distribution

  • 10816843022669 ()


  • Electrode conductive medium

Rochester - 10816843022645

ROCHESTER ELECTRODE JELLY: ORIGINAL SALT JELLY FORMULA
ROCHESTER ELECTRO-MEDICAL, INC.
701500-G
Not in Commercial Distribution

  • 10816843022645 ()


  • Electrode conductive medium

Covidien - 10884521643185

NuPrep Gel
Cardinal Health, Inc.
30806726
In Commercial Distribution

  • 10884521643185 ()
  • 20884521643182 ()

  • Total Volume: 4 Fluid Ounce
30806726

  • Electrode conductive medium

Covidien - 10884521643161

Neurodiagnostic Electrode Paste
Cardinal Health, Inc.
30806692
In Commercial Distribution

  • 20884521643168 ()
  • 10884521643161 ()

  • Total Volume: 4 Fluid Ounce
30806692

  • Electrode conductive medium

Elefix - 10841983102896

Elefix Electrode Adhesive, 400g tubs
NIHON KOHDEN AMERICA, INC.
Z-401CE
In Commercial Distribution

  • 10841983102896 ()
  • 00841983102899 ()
Z-401CE

  • Electrode conductive medium

Medvat - 00850024089235

Conductive Gel
Myt Enterprises LLC
MED-USG-TR-CLEAR-22-2PK-A
In Commercial Distribution

  • 00850024089235 ()


  • Electrode conductive medium

Electrically Conductive Gel (ECG) - 00616784124018

Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water Soluble
Dynarex Corporation
1240
In Commercial Distribution

  • 00616784124018 ()
  • 00616784124032 ()


  • Electrode conductive medium

Electrically Conductive Gel (ECG) - 00616784123912

Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble
Dynarex Corporation
1239
In Commercial Distribution

  • 00616784123912 ()
  • 00616784123936 ()


  • Electrode conductive medium

Elefix - 04931921863312

Electrode Adhesive, 180g tubes
NIHON KOHDEN CORPORATION
Z-181BE
In Commercial Distribution

  • 04931921863312 ()
  • 14931921863319 ()
Z-181BE

  • Electrode conductive medium

Elefix - 04931921818404

Elefix Electrode Adhesive, 400g tubs
NIHON KOHDEN CORPORATION
Z-401CE
In Commercial Distribution

  • 04931921818404 ()
  • 14931921818401 ()
Z-401CE

  • Electrode conductive medium

Elefix - 04931921805749

Elefix Electrode Adhesive, 180g tubes
NIHON KOHDEN CORPORATION
Z-181JE
In Commercial Distribution

  • 04931921805749 ()
  • 14931921805746 ()
Z-181JE

  • Electrode conductive medium

skinPure - 04931921800003

SkinPure Electrode Prep Cream, 135g tube
NIHON KOHDEN CORPORATION
YZ-0019
In Commercial Distribution

  • 04931921800003 ()
  • 14931921800000 ()
YZ-0019

  • Electrocardiograph, professional, multichannel

Elefix V Paste for EEG & EMG - 04931921005842

Elefix Electrode Adhesive, 180g tubes
NIHON KOHDEN CORPORATION
ZV-181E
In Commercial Distribution

  • 04931921005781 ()
  • 04931921005842 ()
  • 04931921005804 ()
ZV-181E

  • Electrode conductive medium

Elefix V Paste for EEG & EMG - 04931921005835

Elefix Electrode Adhesive, 400g tubs
NIHON KOHDEN CORPORATION
ZV-401E
In Commercial Distribution

  • 04931921005767 ()
  • 04931921005835 ()
ZV-401E

  • Electrode conductive medium

Fluoro Care Anti-Fade Mountant - 00847627002471

No Description
BIOCARE MEDICAL LLC
FP001G5
In Commercial Distribution

  • 00847627002471 ()


  • Microscopy mounting medium IVD

Fluoro Care Anti-Fade Mountant - 00847627002464

No Description
BIOCARE MEDICAL LLC
FP001G10
In Commercial Distribution

  • 00847627002464 ()


  • Microscopy mounting medium IVD

SpermFreeze SSP - 05411967005697

SpermFreeze SSP (50ml in PETG bottle) is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.
Fertipro NV
SSP050
In Commercial Distribution

  • 05411967005703 ()
  • 05411967005697 ()

  • Total Volume: 50 Milliliter


  • IVF medium

SpermFreeze SSP - 05411967003440

SpermFreeze SSP SpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.
Fertipro NV
SSP62.5
Not in Commercial Distribution

  • 05411967003457 ()
  • 05411967003440 ()

  • Total Volume: 62.5 Milliliter


  • IVF medium

VitriThaw - 05411967002139

VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT4001
In Commercial Distribution

  • 05411967002139 ()

  • Total Volume: 1 Milliliter


  • IVF medium

VitriThaw - 05411967002122

VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT3001
In Commercial Distribution

  • 05411967002122 ()


  • IVF medium

VitriThaw - 05411967002115

VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT2001
In Commercial Distribution

  • 05411967002115 ()

  • Total Volume: 1 Milliliter


  • IVF medium

VitriThaw - 05411967002108

VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT1005
In Commercial Distribution

  • 05411967002108 ()

  • Total Volume: 5 Milliliter


  • IVF medium

VitriFreeze - 05411967002054

VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. For more information, see DI Number of VitriFreeze kit: 05411967001415 The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VPI005
In Commercial Distribution

  • 05411967002054 ()

  • Total Volume: 5 Milliliter


  • IVF medium

VitriFreeze - 05411967002047

VitriFreeze™ Freezing 2 (REF: VF2001) (1 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. For more information, see DI Number of VitriFreeze kit: 05411967001415 The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VF2001
In Commercial Distribution

  • 05411967002047 ()

  • Total Volume: 1 Milliliter


  • IVF medium

VitriFreeze - 05411967002030

VitriFreeze™ Freezing 1 (REF: VF1001) (1 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. For more information, see DI Number of VitriFreeze kit: 05411967001415 The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VF1001
In Commercial Distribution

  • 05411967002030 ()

  • Total Volume: 1 Milliliter


  • IVF medium

SpermFreeze SSP - 05411967002023

SpermFreeze SSP SpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Fertipro NV
SSP001
In Commercial Distribution

  • 05411967001385 ()
  • 05411967002023 ()

  • Total Volume: 1 Milliliter


  • IVF medium

SpermFreeze - 05411967002016

SpermFreeze SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Fertipro NV
SPF05
In Commercial Distribution

  • 05411967002016 ()
  • 05411967000258 ()

  • Total Volume: 5 Milliliter


  • IVF medium

SpermFreeze - 05411967002009

SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Fertipro NV
SPF
In Commercial Distribution

  • 05411967002009 ()
  • 05411967000265 ()

  • Total Volume: 20 Milliliter


  • IVF medium

VitriThaw - 05411967001439

VitriThaw™ kit containing the following product codes: - VitriThaw Thawing 1 medium (VT1005) DI number: 05411967002108 - VitriThaw Thawing 2 medium (VT2001) DI number: 05411967002115 - VitriThaw Thawing 3 medium (VT3001) DI number: 05411967002122 - VitriThaw Thawing 4 medium (VT4001) DI number: 05411967002139 VitriThaw™ is a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos after vitrification with VitriFreeze™ kit VitriThaw™ media have a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website: www.fertipro.com
Fertipro NV
VT_KIT1
In Commercial Distribution

  • 05411967001439 ()


  • IVF medium

VitriFreeze - 05411967001415

VitriFreeze™ kit containing the following product codes: - VitriFreeze Pre-incubation medium (VPI005) DI number: 05411967002054 - VitriFreeze Freezing 1 medium (VF1001) DI number: 05411967002030 - VitriFreeze Freezing 2 medium (VF2001) DI number: 05411967002047 VitriFreeze™ is a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. VitriFreeze™ media have a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VF_KIT1
In Commercial Distribution

  • 05411967001415 ()


  • IVF medium

SpermFreeze SSP - 05411967001408

SpermFreeze SSP SpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Fertipro NV
SSP125
In Commercial Distribution

  • 05411967000142 ()
  • 05411967001408 ()

  • Total Volume: 125 Milliliter


  • IVF medium

SpermFreeze SSP - 05411967001392

SpermFreeze SSP SpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Fertipro NV
SSP020
In Commercial Distribution

  • 05411967000159 ()
  • 05411967001392 ()

  • Total Volume: 20 Milliliter


  • IVF medium

Sil-Select Stock - 05411967001323

Sil-Select Stock - SIS500 (500 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock has a 18 month shelf life from date of manufacture. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)
Fertipro NV
SIS500
In Commercial Distribution

  • 05411967001323 ()
  • 05411967000630 ()

  • Total Volume: 500 Milliliter


  • IVF medium

Sil-Select Stock - 05411967001316

Sil-Select Stock - SIS100_32 (100 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock has a 18 month shelf life from date of manufacture. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)
Fertipro NV
SIS100_32
In Commercial Distribution

  • 05411967001316 ()
  • 05411967000616 ()

  • Total Volume: 100 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000890

FertiCult™ Mineral Oil - MINOIL050P (50ml in PETG bottle) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL050P
In Commercial Distribution

  • 05411967000890 ()
  • 05411967001149 ()

  • Total Volume: 50 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000883

FertiCult™ Mineral Oil - MINOIL500P (500ml in PETG bottle) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL500P
In Commercial Distribution

  • 05411967000883 ()
  • 05411967001163 ()

  • Total Volume: 500 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000876

FertiCult™ Mineral Oil - MINOIL100_32 (100ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL100_32
In Commercial Distribution

  • 05411967000876 ()
  • 05411967003785 ()

  • Total Volume: 100 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000869

FertiCult™ Mineral Oil - MINOIL100P (100ml in PETG bottle) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL100P
In Commercial Distribution

  • 05411967000869 ()
  • 05411967001156 ()

  • Total Volume: 100 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000852

FertiCult™ Mineral Oil - MINOIL020 (20ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL020
Not in Commercial Distribution

  • 05411967000852 ()

  • Total Volume: 20 Milliliter


  • IVF medium

Sil-Select Stock - 05411967000098

Sil-Select Stock - SIS100 (100 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock has a 18 month shelf life from date of manufacture. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)
Fertipro NV
SIS100
In Commercial Distribution

  • 05411967000098 ()
  • 05411967000593 ()

  • Total Volume: 100 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000081

FertiCult™ Mineral Oil - MINOIL500 (500ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL500
In Commercial Distribution

  • 05411967000081 ()
  • 05411967001132 ()

  • Total Volume: 500 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000074

FertiCult™ Mineral Oil - MINOIL100 (100ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL100
In Commercial Distribution

  • 05411967000074 ()
  • 05411967001125 ()

  • Total Volume: 100 Milliliter


  • IVF medium

FertiCult Mineral Oil - 05411967000067

FertiCult™ Mineral Oil - MINOIL050 (50ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Fertipro NV
MINOIL050
In Commercial Distribution

  • 05411967000067 ()
  • 05411967001118 ()

  • Total Volume: 50 Milliliter


  • IVF medium
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