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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SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000060 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000053 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000046 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000039 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000022 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000015 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AM

  • Depth electrode
GAIT BELT,YELLOW,FALL MGMT,72" 1EA
MEDLINE INDUSTRIES, INC.
MDT821203YL
In Commercial Distribution

  • 10080196374779 ()
MDT821203YL

  • Gait rehabilitation system harness
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system
The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system
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
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
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
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Cerenovus, Inc.
AP-04009
Not in Commercial Distribution

  • 20886704072888 ()
  • 10886704072881 ()
AP04009

  • Implantable intrathecal infusion pump, nonprogrammable
Models 400 and 550 Implantable Infusion Pump Refill Kit
Cerenovus, Inc.
IP-40820
Not in Commercial Distribution

  • 10886704044109 ()
IP40820

  • Implantable intrathecal infusion pump, nonprogrammable
MODEL 400 REFILL TUBING SET
Cerenovus, Inc.
IP40812
Not in Commercial Distribution

  • 10886704044093 ()
IP40812

  • Implantable intrathecal infusion pump, nonprogrammable
3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
Not in Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)
Medos International Sàrl
AP-04032-5
Not in Commercial Distribution

  • 20886704043741 ()
  • 10886704043744 ()
AP040325

  • Implantable intrathecal infusion pump, nonprogrammable
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
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump
Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump
Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump
SafeGait Active 360 system (Model SGA360) is designed to assist a patient with walking/balance impediments to exercise and/or regain normal gait. SafeGait Active 360 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead aluminum rails moved by pulling force from the patient. SafeGait Active 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGA360
In Commercial Distribution

  • 00860012112838 ()


  • Gait rehabilitation frame, electric
SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGAS1000
In Commercial Distribution

  • 00860012112821 ()


  • Gait rehabilitation frame, electric
SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SG360
In Commercial Distribution

  • 00860012112814 ()


  • Gait rehabilitation frame, electric
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
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
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