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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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-SSYM2007A-1
In Commercial Distribution

  • 05712821002273 ()
AS-SSYM2007A-1

  • Dental prosthesis/implant abutment screw
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-SBOM1608A-1
In Commercial Distribution

  • 05712821002266 ()


  • Dental prosthesis/implant abutment screw
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-MUAM1804A-1
In Commercial Distribution

  • 05712821002228 ()


  • Dental implant suprastructure, permanent, preformed
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-MUAM1403A-1
In Commercial Distribution

  • 05712821002211 ()


  • Dental implant suprastructure, permanent, preformed
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-NBAM2007A-1
In Commercial Distribution

  • 05712821002204 ()


  • Dental prosthesis/implant abutment screw
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-NBAM1608A-1
In Commercial Distribution

  • 05712821002198 ()


  • Dental prosthesis/implant abutment screw
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-NBAM1407A-1
In Commercial Distribution

  • 05712821002181 ()


  • Dental prosthesis/implant abutment screw
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-ATOM2010A-1
In Commercial Distribution

  • 05712821002167 ()


  • Dental prosthesis/implant abutment screw
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-ATOM1608A-1
In Commercial Distribution

  • 05712821002150 ()


  • Dental prosthesis/implant abutment screw
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-ATOM1408A-1
In Commercial Distribution

  • 05712821002143 ()


  • Dental prosthesis/implant abutment screw
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-ATEM2008A-1
In Commercial Distribution

  • 05712821002136 ()


  • Dental prosthesis/implant abutment screw
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-ATEM1808A-1
In Commercial Distribution

  • 05712821002129 ()


  • Dental prosthesis/implant abutment screw
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-ATEM1608A-1
In Commercial Distribution

  • 05712821002112 ()


  • Dental prosthesis/implant abutment screw
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-ATEM1408A-1
In Commercial Distribution

  • 05712821002105 ()


  • Dental prosthesis/implant abutment screw
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25730
In Commercial Distribution

  • 05712821000057 ()
  • 05712821009357 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25777
In Commercial Distribution

  • 05712821000040 ()
  • 05712821009418 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25776
In Commercial Distribution

  • 05712821000033 ()
  • 05712821009395 ()


  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
25775
In Commercial Distribution

  • 05712821000026 ()
  • 05712821009449 ()


  • Surgical torque wrench adaptor
Nylon Facing For #1 Mallet
HU-FRIEDY MFG. CO., LLC
PTNFM1
Not in Commercial Distribution

  • 10889950020668 ()
PTNFM1

  • Surgical mallet
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 MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD215
In Commercial Distribution

  • 00862255000347 ()
CD215

  • General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD650
In Commercial Distribution

  • 00862255000330 ()
CD650

  • General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD651
In Commercial Distribution

  • 00862255000323 ()
CD651

  • General-purpose absorbent tip applicator/swab, single-use
No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution

  • 00860540000225 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
Eca Medical Instruments
1005
In Commercial Distribution

  • 00857676008775 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-003
In Commercial Distribution

  • 00857676008768 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-002
In Commercial Distribution

  • 00857676008751 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-001
In Commercial Distribution

  • 00857676008744 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008218 ()
806-004

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008201 ()
806-003

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
2.4 mm Volar Distal Radius Removal Driver
In Commercial Distribution

  • 00857676008195 ()
AR-8924VD-S

  • Surgical screwdriver, single-use
No Description
SYNCARDIA SYSTEMS, LLC
297043-001
In Commercial Distribution

  • 00858000003237 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
297032-100
In Commercial Distribution

  • 00858000003206 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397001-001
In Commercial Distribution

  • 00858000003145 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
595000-001
In Commercial Distribution

  • 00858000003121 ()
  • 10858000003128 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397002-001
In Commercial Distribution

  • 00858000003107 ()


  • Ventricular prosthesis system, pneumatically-powered
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable
Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution

  • 05712149009909 ()
M52366

  • Surgical screwdriver, reusable
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable
Screwdriver hexagon
Oticon Medical AB
M50534
In Commercial Distribution

  • 05712149001026 ()
M50534

  • Surgical screwdriver, reusable
Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).
Oticon Medical AB
M50437
In Commercial Distribution

  • 05712149000654 ()
  • 05712149024568 ()
M50437

  • Surgical screwdriver, reusable
Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable
Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable
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