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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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Zuma Implant, 38mm x 26mm x 20mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3820
Not in Commercial Distribution

  • 10889981037345 ()

  • 38mm x 26mm x 20mm, 8°
55-3820

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 16mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3816
In Commercial Distribution

  • 10889981037321 ()

  • 38mm x 26mm x 16mm, 8°
55-3816

  • Vertebral body prosthesis, non-sterile
Open Lateral Offset. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-24-0020
In Commercial Distribution

  • 10889981033781 ()
16-24-0020

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Extended Rod Caddy BOM. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
NWPEXRIMP
In Commercial Distribution

  • 10889981028213 ()
NWPEXRIMP

  • Vertebral body prosthesis, non-sterile
NewPort Deployer 2 Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
NWD2IMP
In Commercial Distribution

  • 10889981028206 ()
NWD2IMP

  • Vertebral body prosthesis, non-sterile
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates. Also included are 3.7mm locking screws.
Ascension Orthopedics, Inc.
RFOOTIMP
Not in Commercial Distribution

  • M268RFOOTIMP1 ()
  • 10381780064640 ()
RFOOTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates.
Ascension Orthopedics, Inc.
TFSREARFTIMP
Not in Commercial Distribution

  • M268TFSREARFTIMP1 ()
  • 10381780064596 ()
TFSREARFTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Clearmask, LLC
v1.0
In Commercial Distribution

  • 10860005106025 ()
  • 00860005106028 ()
  • 20860005106022 ()
  • 00860005106035 ()


  • Surgical/medical face mask, single-use
The Advanced Instruments 3250 Single-Sample Osmometer is designed for routine osmolality measurement in pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-4000 mOsm.
ADVANCED INSTRUMENTS, INC.
3250
In Commercial Distribution

  • 00816068020870 ()
3250

  • Osmometric analyser IVD, semi-automated
The Fiske 210 Single-Sample Micro-Osmometer is designed for routine osmolality measurement in clinical, pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-2000 mOsm.
ADVANCED INSTRUMENTS, INC.
210
In Commercial Distribution

  • 00816068020863 ()
210

  • Osmometric analyser IVD, semi-automated
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