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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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The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010066 ()
TO-35-CLS-30

  • Orthopaedic bone screw (non-sliding)
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010059 ()
TO-35-CLS-28

  • Orthopaedic bone screw (non-sliding)
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010042 ()
TO-35-CLS-26

  • Orthopaedic bone screw (non-sliding)
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010035 ()
TO-35-CLS-24

  • Orthopaedic bone screw (non-sliding)
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010028 ()
TO-35-CLS-22

  • Orthopaedic bone screw (non-sliding)
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010011 ()
TO-35-CLS-20

  • Orthopaedic bone screw (non-sliding)
Instrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739553 ()
  • 28437019739557 ()


  • Orthopaedic implantation sleeve, reusable
Instrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739577 ()
  • 28437019739571 ()


  • Orthopaedic implantation sleeve, reusable
integrable devices are electronic boards that allow the control of Bien-Air Electric micromotors as well as various dental instruments. They are intended to be integrated into a dental unit (kart or dental chair). iOPTIMA INT and Integrated Dental Unit Platform (IDUP) are dental chair’s integrated device allowing the control of dental and surgical micromotors parameters (such as torque, speed, and direction of rotation), irrigation pump and dental accessories via a user interface. For iOptima INT devices, the user interface is and Apple Device.
Bien-Air Dental SA
1601196-005
In Commercial Distribution

  • J00716011960051 ()


  • Surgical power tool system control unit, line-powered
The Global Reference Module provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 1
In Commercial Distribution

  • 00850011306734 ()
31-0604-0043

  • Electroencephalographic signal amplifier
The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810193 ()

  • Outer Diameter: 18.5 Centimeter
  • Length: 340 Centimeter
80068

  • Medical equipment/instrument drape, single-use
Handheld, battery-powered, ultrasound device intended to measure the thickness of the cornea. The device tip is touched to a patient's eye during the measurement.
REICHERT, INC.
16040
In Commercial Distribution

  • 00812559011228 ()


  • Ultrasound pachymeter
The Para-occlusal Attachment with Support Surface is an accessory of the JMA-Optic facebow and used to attach the lower jaw sensor to the teeth.
zebris MEDICAL GmbH
01960255
In Commercial Distribution

  • B915019602550 ()


  • Facebow
TheraFace Conductive Gel Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Therabody, Inc.
TheraFace Conductive Gel
In Commercial Distribution

  • 00840295408224 ()


  • Electrode conductive medium
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming.
qtec CE-med GmbH
M+L
Not in Commercial Distribution

  • 04262358420091 ()

  • Size M+L
FR003

  • Endoscopic-access dilator, single-use
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming.
qtec CE-med GmbH
S-XL
In Commercial Distribution

  • 04262358420015 ()
  • 04262358420107 ()

  • Size S-XL
FR001

  • Anal fistula circular cutter
Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. The addition of this device provides an additional level of robustness to the mechanism that attaches the inserter to the CurvaFix Implant
Curvafix Inc
RLI-002
In Commercial Distribution

  • 10855068008621 ()
RLI-002

  • Orthopaedic inorganic implant inserter/extractor, reusable
Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. The addition of this device provides an additional level of robustness to the mechanism that attaches the inserter to the CurvaFix Implant
Curvafix Inc
RLI-001
In Commercial Distribution

  • 10855068008591 ()
RLI-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
Mirror for use in the prone position. The cogs fitted to the mirror adjust the height or angle of the Face Guard Helmet to achieve the safest natural neutral neckline.
CARE SURGICAL LIMITED
925.FGM
In Commercial Distribution

  • 05060624125638 ()
925.FGM

  • Patient positioner base plate
Microsurgical - Box Of 10: The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1529036
Not in Commercial Distribution

  • 30381780040242 ()
  • 10381780040248 ()
  • M26915290361 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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