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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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Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7224
In Commercial Distribution

  • 07331791010057 ()

  • Length: 15 Millimeter
7224

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7216
In Commercial Distribution

  • 07331791010040 ()

  • Length: 4.5 Millimeter
7216

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7217
In Commercial Distribution

  • 07331791010033 ()

  • Length: 6 Millimeter
7217

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7218
In Commercial Distribution

  • 07331791010026 ()

  • Length: 8 Millimeter
7218

  • Tracheoesophageal speech valve, indwelling
The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
DILON MEDICAL TECHNOLOGIES LTD
AC0300001
In Commercial Distribution

  • 07290012534034 ()


  • Intraoperative tumour margin analysis probe
The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
DUNE MEDICAL DEVICES LTD
AC0300001
In Commercial Distribution

  • 07290012534010 ()


  • Intraoperative tumour margin analysis probe
The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
GARDIA MEDICAL LTD
P4-9-0703
In Commercial Distribution

P4-9-0703

  • Embolic protection filtering guidewire
The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 72900155120202 1 Retrieval Catheter DI 72900155120309
GARDIA MEDICAL LTD
P2-9-0705-S
Not in Commercial Distribution

  • 72900155120103 ()
P2-9-0705-S

  • Embolic protection filtering guidewire
VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Alafair Biosciences, Inc.
VTP-1201
In Commercial Distribution

  • B454VTP12010 ()

  • Length: 1 Inch
  • Width: 2 Inch
  • Total Volume: 1 Milliliter
  • Length: 2.5 Centimeter
  • Width: 5 Centimeter
VTP-1201

  • Tendon spacer
  • Nerve guide, synthetic polymer, bioabsorbable
The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039
GARDIA MEDICAL LTD
P2-9-0705-S
In Commercial Distribution

P2-9-0705-S

  • Embolic protection filtering guidewire
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