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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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Modern Fertility Pregnancy Test - 00860000599634

Modern Fertility Pregnancy Test 4ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599634 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Modern Fertility Ovulation Test - 00860000599627

Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599627 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Modern Fertility Pregnancy Test - 00860000599610

Modern Fertility Pregnancy Test 2ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599610 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

VirtuOst VFA - 00860000233118

VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233118 ()


  • Radiology DICOM image processing application software

VirtuOst - 00860000233101

VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233101 ()


  • Radiology DICOM image processing application software

G.E.B. tubing - 00860000082808

No Description
A1 SURGICAL SUPPLIES, LLC
A
In Commercial Distribution

  • 50860000082803 ()
  • 00860000082808 ()


  • Suction/irrigation tubing, single-use

SpiroScout SP - 04250972300134

The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 04250972300134 ()
013400562

  • Diagnostic spirometer, professional

ECG cable - 09120073932112

Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073932112 ()
00021

  • General-purpose multi-parameter bedside monitor

ICG cable - 09120073932105

Unit;2.5m, ICG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073932105 ()
00031

  • General-purpose multi-parameter bedside monitor

ICG cable - 09120073931900

Unit;2.5m, ICG cable for Task Force® Monitor with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073931900 ()
00033

  • General-purpose multi-parameter bedside monitor

ECG cable - 09120073931795

Unit;2.5m, ECG cable for Task Force® Monitor with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073931795 ()
00023

  • General-purpose multi-parameter bedside monitor

ICG cable - 09120073930507

Unit;2.5m, ICG cable with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik AG
a
Not in Commercial Distribution

  • 09120073930507 ()
00033

  • Noninvasive haemodynamic monitoring system

ECG cable - 09120073930446

Unit;2.5m, ECG cable with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik AG
a
Not in Commercial Distribution

  • 09120073930446 ()
00023

  • Noninvasive haemodynamic monitoring system

Simplify® Cervical Artificial Disc - 00843285100139

Simplify® Cervical Artificial Disc Size LG, Height 6, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100139 ()

  • Height: 6 Millimeter
  • Angle: 5 degree
LG-6L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100122

Simplify® Cervical Artificial Disc Size LG, Height 6
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100122 ()

  • Height: 6 Millimeter
LG-6

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100115

Simplify® Cervical Artificial Disc Size LG, Height 5, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100115 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
LG-5L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100108

Simplify® Cervical Artificial Disc Size LG, Height 5
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100108 ()

  • Height: 5 Millimeter
LG-5

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100092

Simplify® Cervical Artificial Disc Size MD, Height 6, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100092 ()

  • Height: 6 Millimeter
  • Angle: 5 degree
MD-6L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100085

Simplify® Cervical Artificial Disc Size MD, Height 6
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100085 ()

  • Height: 6 Millimeter
MD-6

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100078

Simplify® Cervical Artificial Disc Size MD, Height 5, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100078 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
MD-5L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100061

Simplify® Cervical Artificial Disc Size MD, Height 5
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100061 ()

  • Height: 5 Millimeter
MD-5

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100054

Simplify® Cervical Artificial Disc Size MD, Height 4
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100054 ()

  • Height: 4 Millimeter
MD-4

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100047

Simplify® Cervical Artificial Disc Size SM, Height 6
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100047 ()

  • Height: 6 Millimeter
SM-6

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100030

Simplify® Cervical Artificial Disc Size SM, Height 5, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100030 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
SM-5L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100023

Simplify® Cervical Artificial Disc Size SM, Height 5
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100023 ()

  • Height: 5 Millimeter
SM-5

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100016

Simplify® Cervical Artificial Disc Size SM, Height 4, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100016 ()

  • Height: 4 Millimeter
  • Angle: 5 degree
SM-4L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100009

Simplify® Cervical Artificial Disc Size SM, Height 4
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100009 ()

  • Height: 4 Millimeter
SM-4

  • Cervical total intervertebral disc prosthesis, modular

ORAFOAM-PKG-18 - 00841336100817

No Description
SALVIN DENTAL SPECIALTIES, LLC
A
In Commercial Distribution

  • 00841336100817 ()


  • Collagen dental regeneration membrane

Perchik Button™ - 10884450786199

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450786192 ()
  • 10884450786199 ()
H787138002015

  • Suture retention device

Prelude Prestige™ - 10884450510701

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450510704 ()
  • 10884450510701 ()

  • Sheath French Size (F)-13F
  • Sheath Length (cm)-13 cm
PLPS-1013

  • Vascular catheter introduction set, nonimplantable

Prelude Prestige™ - 10884450510657

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450510650 ()
  • 10884450510657 ()

  • Sheath French Size (F)-10F
  • Sheath Length (cm)-13 cm
PLPS-1010

  • Vascular catheter introduction set, nonimplantable

Prelude Prestige™ - 10884450510541

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450510544 ()
  • 10884450510541 ()

  • Sheath Length (cm)-25 cm
  • Sheath French Size (F)-12F
PLP-2512

  • Vascular catheter introduction set, nonimplantable

Prelude Prestige™ - 10884450510305

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450510308 ()
  • 10884450510305 ()

  • Sheath Length (cm)-25 cm
  • Sheath French Size (F)-5F
PLP-2505

  • Vascular catheter introduction set, nonimplantable

Prelude Prestige™ - 10884450510206

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450510209 ()
  • 10884450510206 ()

  • Sheath Length (cm)-13 cm
  • Sheath French Size (F)-9.5F
PLP-1009.5

  • Vascular catheter introduction set, nonimplantable

Hydrophilic Prelude SNAP™ - 10884450495480

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450495483 ()
  • 10884450495480 ()

  • Sheath Length (cm)-13 cm
  • Sheath French Size (F)-12.5F
PLSH-1012.5

  • Vascular catheter introduction set, nonimplantable

Prelude SNAP™ - 10884450489656

No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450489659 ()
  • 10884450489656 ()

  • Sheath French Size (F)-12.5F
  • Sheath Length (cm)-13 cm
PLSX-1012.5

  • Vascular catheter introduction set, nonimplantable

Valeo Spacer System - M555916004614

Valeo II 6° 14mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004614 ()

  • Height: 14 Millimeter
91.600.4614

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004613

Valeo II 6° 13mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004613 ()

  • Height: 13 Millimeter
91.600.4613

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004612

Valeo II 6° 12mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004612 ()

  • Height: 12 Millimeter
91.600.4612

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004611

Valeo II 6° 11mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004611 ()

  • Height: 11 Millimeter
91.600.4611

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004610

Valeo II 6° 10mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004610 ()

  • Height: 10 Millimeter
91.600.4610

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004609

Valeo II 6° 9mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004609 ()

  • Height: 9 Millimeter
91.600.4609

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004608

Valeo II 6° 8mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004608 ()

  • Height: 8 Millimeter
91.600.4608

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004607

Valeo II 6° 7mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004607 ()

  • Height: 7 Millimeter
91.600.4607

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004606

Valeo II 6° 6mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004606 ()

  • Height: 6 Millimeter
91.600.4606

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004605

Valeo II 6° 5mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004605 ()

  • Height: 5 Millimeter
91.600.4605

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004014

Valeo II 0° 14mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004014 ()

  • Height: 14 Millimeter
91.600.4014

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004013

Valeo II 0° 13mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004013 ()

  • Height: 13 Millimeter
91.600.4013

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004012

Valeo II 0° 12mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004012 ()

  • Height: 12 Millimeter
91.600.4012

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916004011

Valeo II 0° 11mm Dual Cervical Trial
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555916004011 ()

  • Height: 11 Millimeter
91.600.4011

  • Internal spinal fixation procedure kit, single-use
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