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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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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

Thera-Cream - B872TCT0041

No Description
PRIZM MEDICAL, INC.
TCT004
In Commercial Distribution

  • B872TCT0041 ()


  • Electrode conductive medium

Therabody - 00840295408224

TheraFace Conductive Gel Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Therabody, Inc.
TheraFace Conductive Gel
In Commercial Distribution

  • 00840295408224 ()


  • Electrode conductive medium

Axion - 04260280180335

No Description
Axion USA LLC
20064
In Commercial Distribution

  • 04260280180335 ()


  • Electrode conductive medium

Grass - 00382830043403

EC2® GENUINE GRASS ELECTRODE CREAM
NATUS MANUFACTURING LIMITED
EC2
Not in Commercial Distribution

  • 00382830043403 ()


  • 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

Mounting medium (IFA) - 04049016151999

No Description
EUROIMMUN Medizinische Labordiagnostika AG
ZF 1200-06500-R
In Commercial Distribution

  • 04049016151999 ()


  • Microscopy mounting medium IVD

Mounting Medium - 04049016135715

No Description
EUROIMMUN Medizinische Labordiagnostika AG
ZF 1200-06500
Not in Commercial Distribution

  • 04049016135715 ()


  • Microscopy mounting medium IVD

SAGE Vitrification Warming Kit XL - 60888937027138

SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution.
Coopersurgical, Inc.
ART-8034
In Commercial Distribution

  • 60888937027138 ()


  • IVF medium kit

Sil-Select Plus Upper Layer - 54119670009990

Sil-Select Plus Upper Layer - SIP012UP (12 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP012UP
Not in Commercial Distribution

  • 54119670009990 ()


  • IVF medium

Sil-Select Plus - 54119670001802

Sil-Select Plus™ (SIP016) This kit contains the following product codes: 2 x 20 ml Sil-Select Plus Upper Layer 2 x 20 ml Sil-Select Plus Lower Layer 2 x 20 ml washing/insemination medium Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP016
Not in Commercial Distribution

  • 54119670001802 ()


  • IVF medium

Sil-Select Stock with gentamicin - 54119670012860

Sil-Select Stock with gentamicin - SIS100_32G (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 manufacturer 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
SIS100G (100ml with gentamicin)
Not in Commercial Distribution

  • 54119670012860 ()
  • 05411967000654 ()

  • Total Volume: 100 Milliliter


  • IVF medium

Sil-Select Plus 80% - 54119670012792

Sil-Select Plus™ 80% (SIP80_500) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP80_500
Not in Commercial Distribution

  • 54119670012792 ()


  • IVF medium

Sil-Select Plus 80% - 54119670012488

Sil-Select Plus™ 80% with gentamicin (SIP80_100G) (100ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP80_100G (100ml)
Not in Commercial Distribution

  • 54119670012488 ()


  • IVF medium

Sil-Select Plus 80% - 54119670012310

Sil-Select Plus 80% - SIP80_100 (100 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP80_100 (100ml)
Not in Commercial Distribution

  • 54119670012310 ()


  • IVF medium

Sil-Select Plus 80% - 54119670012242

Sil-Select Plus™ 80% with gentamicin (SIP80_050G) (50 ml ) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP80_050G (50ml)
Not in Commercial Distribution

  • 54119670012242 ()


  • IVF medium

Sil-Select Plus Upper Layer - 54119670012174

Sil-Select Plus™ Upper Layer - SIP500UP (500ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP500UP
Not in Commercial Distribution

  • 54119670012174 ()


  • IVF medium

Sil-Select Plus Upper Layer - 54119670011870

Sil-Select Plus Upper Layer - SIP100UP (100 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP100UP (100ml)
Not in Commercial Distribution

  • 54119670011870 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670011634

Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip
Fertipro NV
SIP100LO_AF (100ml)
Not in Commercial Distribution

  • 54119670011634 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670011566

Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP100LO
Not in Commercial Distribution

  • 54119670011566 ()


  • IVF medium

Sil-Select Plus Upper Layer - 54119670011184

Sil-Select Plus Upper Layer - SIP50UP (50 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP050UP
Not in Commercial Distribution

  • 54119670011184 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670010880

Sil-Select Plus Lower Layer - SIP050LO (50 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP050LO (50ml)
Not in Commercial Distribution

  • 54119670010880 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670010712

Sil-Select Plus Lower Layer - SIP042LO (4,2ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP042LO (4,2ml)
Not in Commercial Distribution

  • 54119670010712 ()


  • IVF medium

Sil-Select Plus Upper Layer - 54119670010644

Sil-Select Plus Upper Layer - SIP025UP (2.5 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP025UP (2,5ml)
Not in Commercial Distribution

  • 54119670010644 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670010576

Sil-Select Plus Lower Layer - SIP025LO (2,5ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP025LO
Not in Commercial Distribution

  • 54119670010576 ()


  • IVF medium

Sil-Select Plus Upper Layer - 54119670010330

Sil-Select Plus Upper Layer - SIP020UP (20 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP020UP
Not in Commercial Distribution

  • 54119670010330 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670010262

Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip
Fertipro NV
SIP020LO_AF (20ml)
Not in Commercial Distribution

  • 54119670010262 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670010194

Sil-Select Plus Lower Layer - SIP020LO (20 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP020LO
Not in Commercial Distribution

  • 54119670010194 ()


  • IVF medium

Sil-Select Plus Lower Layer - 54119670009822

Sil-Select Plus Lower Layer - SIP012LO (12 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP012LO
Not in Commercial Distribution

  • 54119670009822 ()


  • IVF medium

Sil-Select Plus - 54119670001734

Sil-Select Plus™ (SIP008) This kit contains the following product codes: 8 x 2.5 ml Sil-Select Plus Upper Layer 8 x 2.5ml Sil-Select Plus Lower Layer 8 x 2.5 ml washing/insemination medium Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer 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
SIP008
Not in Commercial Distribution

  • 54119670001734 ()


  • IVF medium

SAGE Vitrification Warming Kit - 60888937830486

SAGE Vitrification Warming Kit, ART-8031 (in plastic cryo vials): 2x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution.
Origio A/S
ART-8031
In Commercial Distribution

  • 60888937830486 ()


  • IVF medium kit

SAGE Vitrification Kit - 60888937830448

SAGE Vitrification Kit. ART-8026 (in plastic cryo vials): 2x2 ml ART-8026-A, Equilibration Solution. 2x2 ml ART-8026-B, Vitrification Solution.
Origio A/S
ART-8026
In Commercial Distribution

  • 60888937830448 ()


  • IVF medium kit

EmbryoGen & BlastGen - 60888937819832

EmbryoGen & BlastGen. 2x3 ml
Origio A/S
12062003D
In Commercial Distribution

  • 60888937819832 ()


  • IVF medium kit

Vitrification Warming Kit - 60888937819597

SAGE Vitrification Warming Kit. ART-8030-A: 1x4 ml 1.0M Surose Warming Solution, ART-8030-B: 1x2 ml 0.5M Sucrose Warming Solution, ART-8030-C: 1x6 ml MOPS Solution.
Origio A/S
ART-8030
In Commercial Distribution

  • 60888937819597 ()


  • IVF medium kit

Vitrification Kit - 60888937819511

SAGE Vitriifcation Kit. ART-8025-A: 1x2 ml Equilibration Solution, ART-8025-B: 1x2 ml Vitriifcation Solution.
Origio A/S
ART-8025
In Commercial Distribution

  • 60888937819511 ()


  • IVF medium kit

CSC Thawing Medium Kit - 60888937819429

CSC Thawing Medium Kit. 4x 2 ml CSC Thawing Medium 0.5 M Sucrose, 4x 2 ml CSC Thawing Medium 0.2 M Sucrose, 4x4 ml Wash Medium HEPES Buffered HTF
Origio A/S
ART-8018
In Commercial Distribution

  • 60888937819429 ()


  • IVF medium kit

Quinns Advantage Thaw Kit - 60888937819306

Quinns Advantage Thaw Kit. 3x12 ml
Origio A/S
ART-8016
In Commercial Distribution

  • 60888937819306 ()


  • IVF medium kit
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