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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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SubQ It! Bioabsorbable Skin Closure System - 00867469000220

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable

SubQ It! Bioabsorbable Skin Closure System - 00867469000237

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable

Screwdriver HexaDrive - 05712149027408

Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225).
Oticon Medical AB
265497
In Commercial Distribution

  • 05712149027408 ()
  • 05712149027415 ()
265497

  • Surgical screwdriver, reusable

VYAFUSER™ - 05713495000152

The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Phillips-Medisize A/S
VYAFUSER PUMP KIT US/PR A
In Commercial Distribution

  • 05713495001043 ()
  • 05713495000152 ()
  • 05713495000169 ()

  • Length: 6.7 Inch
  • Width: 3 Inch
  • Depth: 1.3 Inch
  • Weight: 285 Gram
2089870410

  • Ambulatory syringe pump

MultiBase ScanBody - 05712821014665

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
68020522
In Commercial Distribution

  • 05712821014665 ()
68020522

  • Dental implant suprastructure, temporary, preformed, reusable

ScanBody EV (XL) - 05712821014658

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
68020521
In Commercial Distribution

  • 05712821014658 ()
68020521

  • Dental implant suprastructure, temporary, preformed, reusable

ScanBody EV (L) - 05712821014641

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
68020520
In Commercial Distribution

  • 05712821014641 ()
68020520

  • Dental implant suprastructure, temporary, preformed, reusable

ScanBody EV (M) - 05712821014634

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
68020519
In Commercial Distribution

  • 05712821014634 ()
68020519

  • Dental implant suprastructure, temporary, preformed, reusable

ScanBody EV (S) - 05712821014627

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
68020518
In Commercial Distribution

  • 05712821014627 ()
68020518

  • Dental implant suprastructure, temporary, preformed, reusable

ScanBody EV (XS) - 05712821014610

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
68020517
In Commercial Distribution

  • 05712821014610 ()
68020517

  • Dental implant suprastructure, temporary, preformed, reusable
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