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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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Hydrophilic Guidewire for Urinary Tract - 06976055232687

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-18080S
In Commercial Distribution

  • 16976055232684 ()
  • 06976055232687 ()
  • 26976055232681 ()
SF.UA11.B01

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232908

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38080A
In Commercial Distribution

  • 16976055232905 ()
  • 06976055232908 ()
  • 26976055232902 ()
SF.UA11.B23

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232892

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38150S
In Commercial Distribution

  • 16976055232899 ()
  • 06976055232892 ()
  • 26976055232896 ()
SF.UA11.B22

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232885

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-38080S
In Commercial Distribution

  • 16976055232882 ()
  • 06976055232885 ()
  • 26976055232889 ()
SF.UA11.B21

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232878

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35150A
In Commercial Distribution

  • 16976055232875 ()
  • 06976055232878 ()
  • 26976055232872 ()
SF.UA11.B20

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232861

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35080A
In Commercial Distribution

  • 16976055232868 ()
  • 06976055232861 ()
  • 26976055232865 ()
SF.UA11.B19

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232854

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35150S
In Commercial Distribution

  • 16976055232851 ()
  • 06976055232854 ()
  • 26976055232858 ()
SF.UA11.B18

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232847

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-35080S
In Commercial Distribution

  • 16976055232844 ()
  • 06976055232847 ()
  • 26976055232841 ()
SF.UA11.B17

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232830

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32150A
In Commercial Distribution

  • 16976055232837 ()
  • 06976055232830 ()
  • 26976055232834 ()
SF.UA11.B16

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232823

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32080A
In Commercial Distribution

  • 16976055232820 ()
  • 06976055232823 ()
  • 26976055232827 ()
SF.UA11.B15

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232816

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32150S
In Commercial Distribution

  • 16976055232813 ()
  • 06976055232816 ()
  • 26976055232810 ()
SF.UA11.B14

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232809

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-32080S
In Commercial Distribution

  • 16976055232806 ()
  • 06976055232809 ()
  • 26976055232803 ()
SF.UA11.B13

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232793

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-28150A
In Commercial Distribution

  • 16976055232790 ()
  • 06976055232793 ()
  • 26976055232797 ()
SF.UA11.B12

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232786

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-28080A
In Commercial Distribution

  • 16976055232783 ()
  • 06976055232786 ()
  • 26976055232780 ()
SF.UA11.B11

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232779

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-28150S
In Commercial Distribution

  • 16976055232776 ()
  • 06976055232779 ()
  • 26976055232773 ()
SF.UA11.B10

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232762

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-28080S
In Commercial Distribution

  • 16976055232769 ()
  • 06976055232762 ()
  • 26976055232766 ()
SF.UA11.B09

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232755

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-25150A
In Commercial Distribution

  • 16976055232752 ()
  • 06976055232755 ()
  • 26976055232759 ()
SF.UA11.B08

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232731

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-25150S
In Commercial Distribution

  • 16976055232738 ()
  • 06976055232731 ()
  • 26976055232735 ()
SF.UA11.B06

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232717

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-18150A
In Commercial Distribution

  • 16976055232714 ()
  • 06976055232717 ()
  • 26976055232711 ()
SF.UA11.B04

  • Gastro-urological guidewire, single-use

Hydrophilic Guidewire for Urinary Tract - 06976055232694

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.
SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
UIW-18150S
In Commercial Distribution

  • 16976055232691 ()
  • 06976055232694 ()
  • 26976055232698 ()
SF.UA11.B02

  • Gastro-urological guidewire, single-use

Nidacon - 07350025610245

VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast Thaw Kit for optimal recovery of specimens. This product is used for Assisted Reproductive Technology (ART.) procedures.
Nidacon International AB
VitriBlast™ Kit
In Commercial Distribution

  • 07350025610245 ()
VBK-010

  • Spermatozoa/semen motility medium supplement

Oxygen Holder - 00606509800006

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Oxygen Holder is an accessory that attaches to a medical device to hold an oxygen tank.
Pride Mobility Products Corp
Oxygen Holder
In Commercial Distribution

  • 00606509800006 ()
N/A

  • Wheelchair medical gas supply holder

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

i-Cut Power Supply Type A - EAMIICT50500

The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5050
In Commercial Distribution

  • EAMIICT50500 ()


  • Basic power supply, reusable

i-Cut Power Supply - EAMIICT50100

The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5010
In Commercial Distribution

  • EAMIICT50100 ()


  • Basic power supply, reusable

FloProbe 3/8’’ x 3/8” (Non Sterile) - 10814321020176

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080N
Not in Commercial Distribution

  • 10814321020176 ()
  • 00814321020179 ()


  • Electromagnetic blood flowmeter

FloProbe 1/4’’ x 1/4" (Non Sterile) - 10814321020152

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090N
Not in Commercial Distribution

  • 10814321020152 ()
  • 00814321020155 ()


  • Electromagnetic blood flowmeter

Peri-Guard - 00085412530567

Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution

  • 00085412530567 ()
PC0608NBIO

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412530529

Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404N
In Commercial Distribution

  • 00085412530529 ()
PC0404NBIO

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412530628

Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution

  • 00085412530628 ()
PC1225NBIO

  • Cardiovascular patch, animal-derived
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