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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Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04030
Not in Commercial Distribution

  • 20886704043734 ()
  • 10886704043737 ()
AP04030

  • Implantable intrathecal infusion pump, nonprogrammable
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
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
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
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
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
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
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
No Description
HOCOMA AG
V2.0
In Commercial Distribution

  • 07640174660230 ()
31585

  • Mobile gait rehabilitation system, harness-support
Mobility Assist
BIODEX MEDICAL SYSTEMS, INC.
950-570
In Commercial Distribution

  • 00718175005705 ()
950-570

  • Gait rehabilitation electronic walker
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual
Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dynamic body-weight support to the patient as they walk on the treadmill, while simultaneously preventing falls. Clinician seating and footplates can be used for situations where manual-assisted ambulation is desired. The Luminaire System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice ambulating on a treadmill. Luminaire should never be used to lift subjects and should never be connected to inanimate objects. Luminaire should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the Luminaire training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
LU-001
In Commercial Distribution

  • 00850018836272 ()


  • Gait rehabilitation frame, electric
ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution

  • 00850018836265 ()


  • Gait rehabilitation frame, electric
The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution

  • 00850018836258 ()


  • Gait rehabilitation frame, electric
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