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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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TQE Plus Endotoxin 10" Filter Flat 222 Head - 00868277000440

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter

TQE Plus Endotoxin 30" Filter Flat 222 Head - 00868277000433

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-30P3E
Not in Commercial Distribution

  • 20868277000437 ()
  • 10868277000430 ()
  • 00868277000433 ()


  • Peritoneal dialysis system dialysate filter

TQE Plus Endotoxin 20" Filter Flat 222 Head - 00868277000426

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20P3E
Not in Commercial Distribution

  • 10868277000423 ()
  • 00868277000426 ()
  • 20868277000420 ()


  • Peritoneal dialysis system dialysate filter

TQE Plus Endotoxin 10" Filter Flat 222 Head - 00868277000419

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10P3E
Not in Commercial Distribution

  • 10868277000416 ()
  • 00868277000419 ()
  • 20868277000413 ()


  • Peritoneal dialysis system dialysate filter

Elos Accurate Pre-Milled Blank - 05712821010278

The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
PMB-NBA35-10
In Commercial Distribution

  • 05712821010278 ()
PMB-NBA35-10

  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Scan Body 22 - 05712821009906

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBR60-1
In Commercial Distribution

  • 05712821009753 ()
  • 05712821009906 ()
SB-NBR60-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009890

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBR50-1
In Commercial Distribution

  • 05712821009746 ()
  • 05712821009890 ()
SB-NBR50-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009883

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBR43-1
In Commercial Distribution

  • 05712821009739 ()
  • 05712821009883 ()
SB-NBR43-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009876

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBR35-1
In Commercial Distribution

  • 05712821009722 ()
  • 05712821009876 ()
SB-NBR35-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009869

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-NBA60/SINGLE-1
In Commercial Distribution

  • 05712821009715 ()
  • 05712821009869 ()
SB-NBA60/SINGLE-1

  • Dental implant suprastructure, temporary, preformed, reusable
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