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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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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
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-18080A
In Commercial Distribution

  • 16976055232707 ()
  • 06976055232700 ()
  • 26976055232704 ()
SF.UA11.B03

  • Gastro-urological guidewire, single-use
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
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
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-26-WNT-ORB
In Commercial Distribution

  • 00689281035446 ()
03544

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-26-WNT-BLK
In Commercial Distribution

  • 00689281035439 ()
03543

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-26-WNT-PCG
In Commercial Distribution

  • 00689281035422 ()
03542

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-18-WNT-ORB
In Commercial Distribution

  • 00689281035415 ()
03541

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-18-WNT-BLK
In Commercial Distribution

  • 00689281035408 ()
035340

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-18-WNT-PCG
In Commercial Distribution

  • 00689281035392 ()
03539

  • Shower seat, non-powered
6' Electrode Lead Wire Set for use with the Uroval BRS System.
UROVAL, INC.
BR5338 UDI Not Req as is component
In Commercial Distribution

  • 00852523007024 ()

  • Length: 6 Feet


  • Analytical non-scalp cutaneous lead
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
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
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
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
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
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
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-HT
In Commercial Distribution

  • M973BL06161 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-34
Not in Commercial Distribution

  • M973BH201M1 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
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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