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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 Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002514
In Commercial Distribution

  • 10381780120643 ()
  • M268STEM0950025141 ()

  • 3.86 in L x .550 in dia; Size 14
STEM-0950-025-14

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002512
In Commercial Distribution

  • 10381780120636 ()
  • M268STEM0950025121 ()

  • 3.86 in L x .470 in dia; Size 12
STEM-0950-025-12

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002510
In Commercial Distribution

  • 10381780120629 ()
  • M268STEM0950025101 ()

  • 3.86 in L x .390 in dia; Size 10
STEM-0950-025-10

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002508
In Commercial Distribution

  • 10381780120612 ()
  • M268STEM0950025081 ()

  • 3.86 in L x .320 in dia; Size 08
STEM-0950-025-08

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002506
In Commercial Distribution

  • 10381780120605 ()
  • M268STEM0950025061 ()

  • 3.86 in L x .240 in dia; Size 06
STEM-0950-025-06

  • Coated shoulder humeral stem prosthesis
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device.
MEED SKILL SURGICAL
MSS71023A
In Commercial Distribution

  • G429MSS71023A0 ()
MSS71023A

  • Dressing/utility forceps, tweezers-like, single-use
The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible.
ADVANCED CIRCULATORY SYSTEMS INC
12-0707-000
In Commercial Distribution

  • M5921207070000 ()


  • Cardiopulmonary resuscitation kit, reusable
Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials. Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
RELIANCE ORTHODONTIC PRODUCTS INC
BA
In Commercial Distribution

  • D798BA0 ()
BA

  • Orthodontic bracket adhesive
Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials. Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
RELIANCE ORTHODONTIC PRODUCTS INC
1BA
In Commercial Distribution

  • D7981BA0 ()
1 BA

  • Orthodontic bracket adhesive
The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPDIGITIMP
Not in Commercial Distribution

  • M268CAPDIGITIMP1 ()
  • 10381780064503 ()
CAPDIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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