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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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WayPoint™ Combination Driver Bit - 00873263003183

WayPoint Combination Driver Bit
FHC, INC.
66-WP-CD-00318
In Commercial Distribution

  • 00873263003183 ()
66-WP-CD

  • Neurological stereotactic surgery system

WayPoint™ Surgical Kit - 00873263003176

WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1
FHC, INC.
66-WP-MR-00317
Not in Commercial Distribution

  • 00873263001721 ()
  • 00873263003176 ()
66-WP-MR

  • Neurological stereotactic surgery system

Atlas Pro Driver Sterilization Case - 00860540000294

No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable

MatrixPRO Driver Loaner - 00860540000225

No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution

  • 00860540000225 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

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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