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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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ZeroG Gait & Balance System - 00850018836012

The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric

MiE - Gamma Camera Systems - 04260484140074

The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system

MiE - Gamma Camera Systems - 04260484140043

The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system

ECAM-SCINTRON - 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system

HAL for Medical Use - 04560340091091

Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091084

Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091077

Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091060

Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090971

Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539025

The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539018

The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton

Small Pacer - 00850001752244

Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual

Mini Pacer - 00850001752237

Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual

NM - 00195278788252

830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system

MyoSEPCT ES to MyoSPECT Upgrade - 00195278722546

MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system

MyoSPECT ES - 00195278488626

MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system

MyoSPECT - 00195278488619

MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system

MyoSPECT - 00195278421586

MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system

MyoSPECT ES - 00195278421579

MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system

NA - 10886704043720

Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Medos International Sàrl
AP-04013-5
Not in Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043713

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04011
Not in Commercial Distribution

  • 20886704043710 ()
  • 10886704043713 ()
AP04011

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043621

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000UL
Not in Commercial Distribution

  • 10886704043621 ()
AP03000UL

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043614

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000M
Not in Commercial Distribution

  • 10886704043614 ()
AP03000M

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043607

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000L
Not in Commercial Distribution

  • 10886704043607 ()
AP03000L

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043591

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000H
Not in Commercial Distribution

  • 10886704043591 ()
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704078845

Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704078838

FOR USE WITH CODMAN 3000 series IMPLANTABLE DRUG DELIVERY SYSTEM Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set (1) Stopcock (2) Huber Point Needles: 22 Gauge x 1.5" (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (1) Data Sticker (2) Adhesive Bandages (1) Refill Worksheet (1) INSTRUCTIONS FOR USE (2) Instruction Posters
Medos International Sàrl
AP07014US
Not in Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable
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