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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FLEXMESH 8001533-6 1.5 LARGE RIGID
MEDTRONIC PS MEDICAL, INC.
8001533-6
In Commercial Distribution

  • 00721902858796 ()

  • Length: 148.0 Millimeter
  • Height: 0.6 Millimeter
  • Width: 148.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001531-6 148X148MM 0.6MM CP1
MEDTRONIC PS MEDICAL, INC.
8001531-6
In Commercial Distribution

  • 00721902858789 ()

  • Width: 148.0 Millimeter
  • Height: 0.6 Millimeter
  • Length: 148.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001523-6 1.5 MEDIUM RIGID
MEDTRONIC PS MEDICAL, INC.
8001523-6
In Commercial Distribution

  • 00721902858765 ()

  • Width: 77.0 Millimeter
  • Length: 113.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-6 1.5 MEDIUM STANDARD
MEDTRONIC PS MEDICAL, INC.
8001521-6
In Commercial Distribution

  • 00721902858758 ()

  • Length: 113.0 Millimeter
  • Width: 77.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-3 1.5 MEDIUM THIN
MEDTRONIC PS MEDICAL, INC.
8001521-3
In Commercial Distribution

  • 00721902858741 ()

  • Length: 113.0 Millimeter
  • Height: 0.3 Millimeter
  • Width: 77.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-6 1.5 SML STANDARD
MEDTRONIC PS MEDICAL, INC.
8001511-6
In Commercial Distribution

  • 00721902858727 ()

  • Height: 0.6 Millimeter
  • Width: 50.0 Millimeter
  • Length: 56.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-3 1.5 SML THIN
MEDTRONIC PS MEDICAL, INC.
8001511-3
In Commercial Distribution

  • 00721902858710 ()

  • Width: 50.0 Millimeter
  • Length: 56.0 Millimeter
  • Height: 0.3 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
INSTRUMENT 7480156 NON BRKOFF PLUG STRTR
MEDTRONIC SOFAMOR DANEK, INC.
7480156
In Commercial Distribution

  • 00721902857607 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480147 DRV QUICK CONNECT T27
MEDTRONIC SOFAMOR DANEK, INC.
7480147
In Commercial Distribution

  • 00721902857089 ()


  • Surgical screwdriver, reusable
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
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
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution

  • 00862712000309 ()

  • Width: 20 Centimeter
  • Weight: 155 Gram
  • Length: 22.86 Centimeter
  • Height: 15.87 Centimeter
10001

  • Hair growth laser device
No Description
PRO-DEX, INC.
KLS-SD-1000-NTL
In Commercial Distribution

  • 00862377000188 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-CA-001-1
In Commercial Distribution

  • 00862377000171 ()


  • Screwing power tool attachment
No Description
PRO-DEX, INC.
APD-1000-1
In Commercial Distribution

  • 00862377000164 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
KLS-SD-1000
In Commercial Distribution

  • 00862377000133 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
05.000.021S
In Commercial Distribution

  • 00862377000119 ()
  • 10862377000116 ()
  • 20862377000113 ()


  • Disposable battery pack
No Description
PRO-DEX, INC.
05.000.020
In Commercial Distribution

  • 00862377000102 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
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
68020504
In Commercial Distribution

  • 05712821013620 ()
68020504

  • Dental implant suprastructure, temporary, preformed, reusable
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
68020501
In Commercial Distribution

  • 05712821013613 ()
68020501

  • Dental implant suprastructure, temporary, preformed, reusable
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
68020500
In Commercial Distribution

  • 05712821013606 ()
68020500

  • Dental implant suprastructure, temporary, preformed, reusable
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-CBA43-1
In Commercial Distribution

  • 05712821013057 ()
  • 05712821013194 ()
SB-CBA34-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-CAS50-1
In Commercial Distribution

  • 05712821013040 ()
  • 05712821013187 ()
SB-CAS50-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-CAS43-1
In Commercial Distribution

  • 05712821013033 ()
  • 05712821013170 ()
SB-CAS43-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-CAS38-1
In Commercial Distribution

  • 05712821013026 ()
  • 05712821013163 ()
SB-CAS38-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-CAS33-1
In Commercial Distribution

  • 05712821013019 ()
  • 05712821013156 ()
SB-CAS33-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-BCE41-1
In Commercial Distribution

  • 05712821013002 ()
  • 05712821013149 ()
SB-BCE41-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-BCE34-1
In Commercial Distribution

  • 05712821012999 ()
  • 05712821013132 ()
SB-BCE34-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-ZSV57-1
In Commercial Distribution

  • 05712821012982 ()
  • 05712821013125 ()
SB-ZSV57-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-ZSV35-1
In Commercial Distribution

  • 05712821012968 ()
  • 05712821013101 ()
SB-ZSV35-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-NGA35-1
In Commercial Distribution

  • 05712821012951 ()
  • 05712821013095 ()
SB-NGA35-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-NGM45-1
In Commercial Distribution

  • 05712821012944 ()
  • 05712821013088 ()
SB-NGM45-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-HET35-1
In Commercial Distribution

  • 05712821012920 ()
  • 05712821013064 ()
SB-HET35-1

  • Dental implant suprastructure, temporary, preformed, reusable
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/BRIDGE-1
In Commercial Distribution

  • 05712821011442 ()
  • 05712821011473 ()
SB-NBA60/BRIDGE-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-NBA43/BRIDGE-1
In Commercial Distribution

  • 05712821011435 ()
  • 05712821011466 ()
SB-NBA43/BRIDGE-1

  • Dental implant suprastructure, temporary, preformed, reusable
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-NBA35/BRIDGE-1
In Commercial Distribution

  • 05712821011428 ()
  • 05712821011459 ()
SB-NBA35/BRIDGE-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-SBXM1606A-1
In Commercial Distribution

  • 05712821011275 ()
AS-SBXM1606A-1

  • Dental prosthesis/implant abutment screw
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