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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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Eigr™ Waveguide - 00816728020059

The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Narrow / Flat, LC
In Commercial Distribution

  • 00816728020059 ()

  • Angle: Flat
  • Width: Narrow
CEW1NF

  • Surgical instrument fibreoptic light

ARK™ UR-144/JWH-018 Control - 00812101030288

ARK™ UR-144/JWH-018 Control is intended for use in quality control of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0003-00
In Commercial Distribution

  • 00812101030288 ()
5054-0003-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control

ARK™ UR-144/JWH-018 Cutoff Calibrator - 00812101030271

ARK™ UR-144/JWH-018 Cutoff Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0002-02
In Commercial Distribution

  • 00812101030271 ()
5054-0002-02

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator

ARK™ UR-144/JWH-018 Negative Calibrator - 00812101030264

ARK™ UR-144/JWH-018 Negative Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0002-01
In Commercial Distribution

  • 00812101030264 ()
5054-0002-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator

Zuma™ - 10889981037482

Locking Cover, 22mm. 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
55-6022
Not in Commercial Distribution

  • 10889981037482 ()

  • 22mm
55-6022

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037475

Locking Cover, 20mm. 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
55-6020
In Commercial Distribution

  • 10889981037475 ()

  • 20mm
55-6020

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037468

Locking Cover, 18mm. 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
55-6018
In Commercial Distribution

  • 10889981037468 ()

  • 18mm
55-6018

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037451

Locking Cover, 16mm. 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
55-6016
In Commercial Distribution

  • 10889981037451 ()

  • 16mm
55-6016

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037444

Locking Cover, 14mm. 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
55-6014
In Commercial Distribution

  • 10889981037444 ()

  • 14mm
55-6014

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037437

Locking Cover, 12mm. 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
55-6012
In Commercial Distribution

  • 10889981037437 ()

  • 12mm
55-6012

  • Vertebral body prosthesis, non-sterile
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