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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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4.0mm x 28mm Smooth Shaft Poly Screw Assm. 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
16-13-4028
In Commercial Distribution

  • 10889981052805 ()

  • 4.0mm x 28mm
16-13-4028

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 38mm Smooth Shaft Poly Screw Assm. 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
16-13-3538
In Commercial Distribution

  • 10889981052744 ()

  • 3.5mm x 38mm
16-13-3538

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 36mm Smooth Shaft Poly Screw Assm. 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
16-13-3536
In Commercial Distribution

  • 10889981052737 ()

  • 3.5mm x 36mm
16-13-3536

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 20mm Smooth Shaft Poly Screw Assm. 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
16-13-3520
In Commercial Distribution

  • 10889981052652 ()

  • 3.5mm x 20mm
16-13-3520

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 18mm Smooth Shaft Poly Screw Assm. 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
16-13-3518
In Commercial Distribution

  • 10889981052645 ()

  • 3.5mm x 18mm
16-13-3518

  • Bone-screw internal spinal fixation system, non-sterile
Arched Rod to Rod Cross Connector(45-35mm) Assm. 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
16-22-4535
In Commercial Distribution

  • 10889981033873 ()

  • 45-35mm
16-22-4535

  • Bone-screw internal spinal fixation system, non-sterile
Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative grafts The kit includes dental screws TX and neccessary accessories. The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. The following screws are included: 7pcs TCT09 007, 7pcs TCT09 010, 3pcs TCT10 007, 3pcs TCT10 010
Hager & Meisinger Gesellschaft mit beschränkter Haftung
BTX00
In Commercial Distribution

BTX00

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072975
In Commercial Distribution

  • 00816270020378 ()
20072975

  • Cystic fibrosis IVD, kit, multiplex
The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box. • With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances. • The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.
NIDEK CO.,LTD.
TS-310
In Commercial Distribution

  • 04987669101414 ()


  • Vision testing/training chart
  • Phoropter
Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.
Seaspine Orthopedics Corporation
36-5114
Not in Commercial Distribution

  • 10889981035211 ()

  • 50mm x 18mm x 14mm, 0 degrees
36-5114

  • Vertebral body prosthesis, non-sterile
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