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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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SPERMCARE Upper Layer - Gradient System - 00859268006183

SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
INVITROCARE, INCORPORATED
2221-50
In Commercial Distribution

  • 00859268006183 ()
2221-50

  • IVF medium

SPERMCARE 100% - Gradient System - 00859268006176

SPERMCARE 100% - Gradient System is a 100% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE 100% - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
INVITROCARE, INCORPORATED
2220-100
In Commercial Distribution

  • 00859268006176 ()
2220-100

  • IVF medium

MINERAL OIL - Oil for Tissue Culture - 00859268006169

MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
INVITROCARE, INCORPORATED
2011-5
In Commercial Distribution

  • 00859268006169 ()
2011-5

  • IVF medium

MINERAL OIL - Oil for Tissue Culture - 00859268006152

MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
INVITROCARE, INCORPORATED
2011
In Commercial Distribution

  • 00859268006152 ()
2011

  • IVF medium

HYALURONIDASE - 00859268006145

InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
INVITROCARE, INCORPORATED
2212
In Commercial Distribution

  • 00859268006145 ()
2212

  • IVF medium

PVP - Polyvinylpyrrolidone - 00859268006138

InVitroCare's Polyvinylpyrrolidone (PVP) reagent is composed of polyvinylpyrrolidone (MW:360,000) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. PVP is intended for use as a medium for the immobilization and isolation of single sperm cells during intracytoplasmic sperm injection (ICSI) procedures.
INVITROCARE, INCORPORATED
2210
In Commercial Distribution

  • 00859268006138 ()
2210

  • IVF medium

HUMAN SERUM ALBUMIN - 00859268006114

HUMAN SERUM ALBUMIN consists of human serum albumin from therapeutic-grade source material at a concentration of 100mg/ml in a sterile saline solution. HUMAN SERUM ALBUMIN is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.
INVITROCARE, INCORPORATED
2101-1
In Commercial Distribution

  • 00859268006114 ()
2101-1

  • IVF medium

IVC-THREE Blastocyst Medium - 00859268006107

IVC-THREE Blastocyst Medium is a synthetic, defined culture medium composed of a balanced mixture of salts, amino acid, vitamins and other nutrients designed to support embryo growth and blastocyst development in vitro. IVC-THREE Blastocyst Medium has been formulated without phosphate, which may be detrimental to blastocyst development (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-THREE Blastocyst Medium may be used as a stand alone medium or as the second stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2007-V
In Commercial Distribution

  • 00859268006107 ()
2007-V

  • IVF medium

IVC-TWO - 00859268006091

IVC-TWO is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.The formulation of IVC-TWO is substantially equivalent to the glucose and phosphate free HTF formulation published by Quinn et al (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-TWO is designed to support early stages of embryonic growth (up to four days post-fertilization). IVC-TWO has been formulated without phosphate, which may be detrimental to embryo blastocyst development. IVC-TWO may be used as a stand alone medium or as the first stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2008-V
In Commercial Distribution

  • 00859268006091 ()
2008-V

  • IVF medium

SPERM WASH MEDIUM - 00859268006084

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2003-K75
In Commercial Distribution

  • 00859268006084 ()
2003-K75

  • IVF medium

SPERM WASH MEDIUM - 00859268006077

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2003-K2
In Commercial Distribution

  • 00859268006077 ()
2003-K2

  • IVF medium

SPERM WASH MEDIUM - 00859268006060

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2005-5
In Commercial Distribution

  • 00859268006060 ()
2005-5

  • IVF medium

SPERM WASH MEDIUM - 00859268006053

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2005
In Commercial Distribution

  • 00859268006053 ()
2005

  • IVF medium

SPERM WASH MEDIUM - 00859268006039

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2003-1
In Commercial Distribution

  • 00859268006039 ()
2003-1

  • IVF medium

HTF HEPES - 00859268006022

HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). HTF HEPES uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2002-5
In Commercial Distribution

  • 00859268006022 ()
2002-5

  • IVF medium

HTF HEPES - 00859268006015

HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). HTF HEPES uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2002
In Commercial Distribution

  • 00859268006015 ()
2002

  • IVF medium

HTF culture medium - 00859268006008

HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
INVITROCARE, INCORPORATED
2001
In Commercial Distribution

  • 00859268006008 ()
2001

  • IVF medium

Epredia - 00673693275194

ClearVue™ Mountant XYL is a xylene-based rapid drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage. ClearVue Mountant is approved specifically for use with the ClearVue coverslipper.
RICHARD-ALLAN SCIENTIFIC COMPANY
ClearVue™ XYL Mountant
In Commercial Distribution

  • 00673693275194 ()
4212

  • Microscopy mounting medium IVD

Epredia - 00673693270427

ClearVue™ Mountant is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage. ClearVue Mountant is approved specifically for use with the ClearVue coverslipper.
RICHARD-ALLAN SCIENTIFIC COMPANY
ClearVue™ Mountant
In Commercial Distribution

  • 00673693270427 ()
4211

  • Microscopy mounting medium IVD

Epredia - 00673693170383

Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mounting Medium
In Commercial Distribution

  • 00673693170383 ()
4112

  • Microscopy mounting medium IVD

Epredia - 00673693169745

Cytoseal™ XYL is a xylene-based mounting medium that contains an antioxidant to inhibit the fading or yellowing of stained specimens. It is a rapid-drying medium allowing microscopic examination of slides soon after application.
RICHARD-ALLAN SCIENTIFIC COMPANY
Cytoseal™ XYL
In Commercial Distribution

  • 00673693169745 ()
8312-16E

  • Microscopy mounting medium IVD

NuFACE - 00854278006864

Leave-On Gel Primer 2oz. -
Nuface
30410
In Commercial Distribution

  • 00854278006864 ()


  • Electrode conductive medium

NuFACE - 00854278006857

Leave-On Gel Primer 5oz
Nuface
30420
In Commercial Distribution

  • 00854278006857 ()


  • Electrode conductive medium

QB1 Electrode Gel - 00854816006042

QB1 Electrode Gel
Motive Health, Inc.
QB-1000-006
In Commercial Distribution

  • 00854816006042 ()
QB-1000-006

  • Electrode conductive medium

1% KCl GEL - 00855683006920

Bulk packed 1% KCl gel
PARKER LABORATORIES INC
99-01-730090
In Commercial Distribution

  • 00855683006920 ()
99-01-730090

  • Electrode conductive medium

BioWrap - 00855683006852

BioWrap Conductive Cream
PARKER LABORATORIES INC
17-04-155714
In Commercial Distribution

  • 10855683006859 ()
  • 00855683006852 ()


  • Electrode conductive medium

gammaCore™ - 00855683006685

Highly Conductive Multi-Purpose Electrolyte Gel 60g
PARKER LABORATORIES INC
Electrolyte Gel
In Commercial Distribution

  • 00855683006685 ()
40000-00103

  • Electrode conductive medium

innovo Spray - 00855683006678

Electrode Solution & Skin Prep (250 ml)
PARKER LABORATORIES INC
18-52-970605
In Commercial Distribution

  • 10855683006675 ()
  • 00855683006678 ()
  • 20855683006672 ()


  • Electrode conductive medium

Rebuilder - 00855683006661

Rebuilder Electrolyte 1 gallon
PARKER LABORATORIES INC
Rebuilder Electrolyte 1 gallon
In Commercial Distribution

  • 10855683006668 ()
  • 00855683006661 ()
  • 20855683006665 ()
99-28-155446

  • Electrode conductive medium

Rebuilder - 00855683006654

Rebuilder Electrolyte 250 ml Spray
PARKER LABORATORIES INC
Rebuilder Electrolyte 250 ml Spray
In Commercial Distribution

  • 10855683006651 ()
  • 00855683006654 ()
  • 20855683006658 ()
99-25-155446

  • Electrode conductive medium

Taylor Industries - 00855683006616

5 Gallon Electrode Gel Pails
PARKER LABORATORIES INC
Electrode Gel
In Commercial Distribution

  • 00855683006616 ()
99-05-155474

  • Electrode conductive medium

Grass EC3 - 00855683006586

Conductive Adhesive Gel, 50 gram tube
PARKER LABORATORIES INC
Conductive Adhesive Gel
In Commercial Distribution

  • 00855683006586 ()
22-60-730080

  • Electrode conductive medium

SIGNASPRAY - 00855683006500

Signaspray Electrode Solution, 1 gallon bottle
PARKER LABORATORIES INC
ELECTRODE SOLUTION AND SKIN PREP
In Commercial Distribution

  • 10855683006507 ()
  • 00855683006500 ()
18-04

  • Electrode conductive medium

Parker Labs - 00855683006272

Signaspray Electrode Solution, one gallon bottle
PARKER LABORATORIES INC
Signaspray Electrode Solution
In Commercial Distribution

  • 00855683006272 ()
  • 10855683006279 ()
  • 20855683006276 ()
18-28

  • Electrode conductive medium

SIGNACREME - 00855683006241

SIGNACREME ELECTRODE CREME 1/2 GAL BOTTLE.
PARKER LABORATORIES INC
ELECTRODE CREAM
In Commercial Distribution

  • 20855683006245 ()
  • 10855683006248 ()
  • 00855683006241 ()
17-20

  • Electrode conductive medium

Medvat - 00850024089235

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

  • 00850024089235 ()


  • Electrode conductive medium

Serum Substitute Supplement™ - 00893727002972

Serum Substitute Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
99193-100ML
In Commercial Distribution

  • 00893727002972 ()

  • Total Volume: 100 Milliliter
99193

  • IVF medium

Sperm Maintenance Medium - 00893727002965

Sperm Maintenance Medium
FUJIFILM IRVINE SCIENTIFIC, INC.
99176-100ml
Not in Commercial Distribution

  • 00893727002965 ()

  • Total Volume: 100 Milliliter
99176

  • IVF medium

Human Serum Albumin Solution - 00893727002903

Human Albumin
FUJIFILM IRVINE SCIENTIFIC, INC.
9988-100mL
In Commercial Distribution

  • 00893727002903 ()

  • Total Volume: 100 Milliliter
9988

  • IVF medium

Modified Ham's F-10 Basal Medium - HEPES - 00893727002835

Modified Ham's F-10 Basal Medium - HEPES
FUJIFILM IRVINE SCIENTIFIC, INC.
99168-100ML
Not in Commercial Distribution

  • 00893727002835 ()

  • Total Volume: 100 Milliliter
99168

  • IVF medium
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