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

  • 04049016151999 ()


  • Microscopy mounting medium IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
ZF 1200-06500
Not in Commercial Distribution

  • 04049016135715 ()


  • Microscopy mounting medium IVD
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
VITROMED GmbH
V-OSM-60
In Commercial Distribution

  • 04260650072437 ()
  • 04260650073137 ()
V-OSM-60

  • IVF medium
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
VITROMED GmbH
V-OSM-20
In Commercial Distribution

  • 04260650071614 ()
  • 04260650070914 ()
V-OSM-20

  • IVF medium
V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.
VITROMED GmbH
V-HTF-P1
In Commercial Distribution

  • 04260650070723 ()
  • 04260650071423 ()


  • IVF medium
V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) medium and Human Serum Albumin (HSA). V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
VITROMED GmbH
V-PVP-7
In Commercial Distribution

  • 04260650071034 ()


  • IVF medium
V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: - 2 vials of Thawing Solution (TS), with red caps and labels. - 1 vial of Diluent Solution (DS), with a yellow cap and label. - 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
VITROMED GmbH
V-TS-KIT
In Commercial Distribution

  • 04260650070297 ()
  • 04260650070341 ()


  • IVF medium
V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package: -1 vial of Equilibration Solution (ES), with a blue cap and label. - 2 vials of Vitrification Solution (VS), with green caps and labels. V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
VITROMED GmbH
V-FS-KIT
In Commercial Distribution

  • 04260650070273 ()
  • 04260650070327 ()


  • IVF medium
V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).
VITROMED GmbH
V-HYA
In Commercial Distribution

  • 04260650071836 ()
  • 04260650070136 ()


  • IVF medium
V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim-up method and holdingsperm for IUI procedure.
VITROMED GmbH
V-SWM-100
In Commercial Distribution

  • 04260650071805 ()
  • 04260650070105 ()


  • IVF medium
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
VITROMED GmbH
V-OSM-20P
In Commercial Distribution

  • 04260650070020 ()
  • 04260650071720 ()
V-OSM-20P

  • IVF medium
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
VITROMED GmbH
V-OSM-10
In Commercial Distribution

  • 04260650070013 ()
  • 04260650071713 ()
V-OSM-10

  • IVF medium
EEG-ACP adhesive conductive paste, 10x 100 g
CNSAC Medshop GmbH
CR-050c
In Commercial Distribution

  • 04262356159993 ()


  • Electrode conductive medium
For use as a permanent, resin based mounting medium in histological preparations on slides produced by SectionStar™
Clarapath, Inc.
900-00023
In Commercial Distribution

  • 00860012688937 ()
  • 10860012688934 ()


  • Microscopy mounting medium IVD
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

  • 00673693088978 ()
8312-4

  • Microscopy mounting medium IVD
Cytoseal™ 280 is a toluene-based mounting medium formulated from acrylic resins and will not crack or discolor with age. The addition of antioxidants inhibits fading or yellowing of stained specimens. This is a high-viscosity medium for applications where minimal spreading is desired.
RICHARD-ALLAN SCIENTIFIC COMPANY
Cytoseal™ 280
In Commercial Distribution

  • 00673693088961 ()
8311-4

  • Microscopy mounting medium IVD
Cytoseal™ 60 is a toluene-based mounting medium formulated from acrylic resins and will not crack or discolor with age. The addition of antioxidants inhibits fading or yellowing of stained specimens. This is a low-viscosity medium that dries quickly and allows for rapid, even spreading which virtually eliminates air bubbles.
RICHARD-ALLAN SCIENTIFIC COMPANY
Cytoseal™ 60
In Commercial Distribution

  • 00673693088954 ()
8310-4

  • Microscopy mounting medium IVD
Cytoseal™ 60 is a toluene-based mounting medium formulated from acrylic resins and will not crack or discolor with age. The addition of antioxidants inhibits fading or yellowing of stained specimens. This is a low-viscosity medium that dries quickly and allows for rapid, even spreading which virtually eliminates air bubbles.
RICHARD-ALLAN SCIENTIFIC COMPANY
Cytoseal™ 60
In Commercial Distribution

  • 00673693088947 ()
8310-16

  • Microscopy mounting medium IVD
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

  • 00673693073189 ()
4111

  • Microscopy mounting medium IVD
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
2212-10
In Commercial Distribution

  • 00859268006305 ()
2212-10

  • IVF medium
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-L
In Commercial Distribution

  • 00859268006282 ()
2005-L

  • IVF medium
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 metal (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-L
In Commercial Distribution

  • 00859268006275 ()
2002-L

  • IVF medium
SPERM FREEZING MEDIUM - SpermFreeze is a HEPES buffered freezing medium for use with human sperm. It contains 0.4% human serum albumin. SPERM FREEZING MEDIUM - SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
INVITROCARE, INCORPORATED
2230
In Commercial Distribution

  • 00859268006237 ()
2230

  • IVF medium
SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
INVITROCARE, INCORPORATED
2222-K1
In Commercial Distribution

  • 00859268006220 ()
2222-K1

  • IVF medium
SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
INVITROCARE, INCORPORATED
2222-100
In Commercial Distribution

  • 00859268006213 ()
2222-100

  • IVF medium
SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
INVITROCARE, INCORPORATED
2222-50
In Commercial Distribution

  • 00859268006206 ()
2222-50

  • IVF medium
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
2221-100
In Commercial Distribution

  • 00859268006190 ()
2221-100

  • IVF medium
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 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 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 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
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
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 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 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 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 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 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 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 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 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 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 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 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
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501G-100-500
In Commercial Distribution

  • 00858604006245 ()


  • Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501G-100-250
In Commercial Distribution

  • 00858604006238 ()


  • Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501G-100-100
In Commercial Distribution

  • 00858604006221 ()


  • Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501G-100-50
In Commercial Distribution

  • 00858604006214 ()


  • Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501GR-90-250
In Commercial Distribution

  • 00858604006207 ()


  • Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
HAMILTON THORNE, INC.
4GM501GR-90-100
In Commercial Distribution

  • 00858604006191 ()


  • Cell centrifugation/density gradient separation reagent IVD
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