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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RC R-MIX SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-96-0102-24
In Commercial Distribution

  • 30014613335832 ()
F-96-0102-24

  • Cell culture line IVD
SUPER E-MIX READYCELLS-24 VIAL
DIAGNOSTIC HYBRIDS, INC.
F-92-0102-24
In Commercial Distribution

  • 30014613335825 ()
F-92-0102-24

  • Cell culture line IVD
RC HS27 SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-87-0102-24
In Commercial Distribution

  • 30014613335818 ()
F-87-0102-24

  • Cell culture line IVD
RC MCCOY SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-54-0102-24
In Commercial Distribution

  • 30014613335801 ()
F-54-0102-24

  • Cell culture line IVD
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()


  • Surgical plume evacuation system
Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()


  • Surgical plume evacuation system
Smoke Evacuator 110V
Covidien LP
SE3690ZD
In Commercial Distribution

  • 10884521134140 ()


  • Surgical plume evacuation system
Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block
Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block
No Description
I.C. MEDICAL, INC.
ICM-000-0561
In Commercial Distribution

  • 00817688022411 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0546
In Commercial Distribution

  • 00817688021759 ()


  • Surgical plume evacuation system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
4.25mm dia.12mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12V
In Commercial Distribution

  • 90810005669170 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
3.75mm dia.14mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-375-14V
In Commercial Distribution

  • 90810005669125 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.14mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
QUIKLINK Automatic Activation Device for SMOKE-E-VAC Smoke Plume Evacuator
Conmed Corporation
QUIKLINK
In Commercial Distribution

  • 30845854061231 ()
QUIKLINK

  • Surgical plume evacuation system
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Tecapro mt.
Innovasis, Inc.
LS-215
In Commercial Distribution

  • M711LS2150 ()
LS-215

  • Bone graft packing block
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
AZIYO BIOLOGICS, INC.
CMCV-060-402
In Commercial Distribution

  • 10859389005017 ()
  • 00859389005010 ()

  • Width: 7.0 Centimeter
  • Height: 15.0 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
AZIYO BIOLOGICS, INC.
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-067-404
In Commercial Distribution

  • 10859389005055 ()
  • 00859389005058 ()

  • Width: 7 Centimeter
  • Height: 4 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-064-401
In Commercial Distribution

  • 10859389005048 ()
  • 00859389005041 ()

  • Width: 7 Centimeter
  • Height: 10 Centimeter


  • Cardiovascular patch, animal-derived
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.
DERMATOLOGIC LAB AND SUPPLY, INC.
9006290
In Commercial Distribution

  • D69190062901 ()
  • D69190062900 ()
9006290

  • Surgical plume evacuation system
Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 220V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006298
In Commercial Distribution

  • D69190062980 ()
9006298

  • Surgical plume evacuation system
Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006300
In Commercial Distribution

  • D69190063000 ()
9006300

  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type N-4 mm
In Commercial Distribution

  • 07290114063258 ()
190-000117-15

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114063241 ()
190-000117-14

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type D
In Commercial Distribution

  • 07290114063227 ()
190-000117-12

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type E&F
In Commercial Distribution

  • 07290114063111 ()
190-000117-08

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type I
In Commercial Distribution

  • 07290114063104 ()
190-000117-07

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114063081 ()
190-000117-04

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type J
In Commercial Distribution

  • 07290114063074 ()
190-000117-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type H
In Commercial Distribution

  • 07290114063128 ()
190-000117-09

  • Depth electrode
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