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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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

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
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
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 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
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-03000L
Not in Commercial Distribution

  • 10886704043607 ()
AP03000L

  • Implantable intrathecal infusion pump, nonprogrammable
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
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