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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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PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-114
Not in Commercial Distribution

  • 10381780113683 ()

  • 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-114

  • Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-108
Not in Commercial Distribution

  • 10381780113676 ()

  • 8 x 8 x (0.20 - 1.04) cm x cm x mm
6495-9-108

  • Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-106
Not in Commercial Distribution

  • 10381780113669 ()

  • 6 x 6 x (0.20 - 1.04) cm x cm x mm
6495-9-106

  • Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-104
Not in Commercial Distribution

  • 10381780113652 ()

  • 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-104

  • Animal-derived wound matrix dressing
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 medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution

  • 07613365003765 ()
  • 07613365003697 ()
1A.306010

  • Electrocardiographic ambulatory recorder
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.
3080S
Not in Commercial Distribution

  • 00814321020186 ()


  • 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.
3090S
Not in Commercial Distribution

  • 00814321020162 ()


  • Electromagnetic blood flowmeter
BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA.
BresoTec Inc
BTSM1US-URU
In Commercial Distribution

  • 00990008600022 ()


  • Home-use sleep apnoea recording system
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
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