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, 3x5 CONTACTS, EXPLORATION LENGTH 62MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000169 ()

  • Special Insulating Length between groups of 5 contacts 7 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15BT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 62MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000152 ()

  • Special Insulating Length between groups of 5 contacts 7 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15BM

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x6 CONTACTS, EXPLORATION LENGTH 80.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000145 ()

  • Special Insulating Length between groups of 6 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18CT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x6 CONTACTS, EXPLORATION LENGTH 80.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000138 ()

  • Special Insulating Length between groups of 6 contacts 11 Millimeters
  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-18CM

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000121 ()

  • Special Insulating Length between groups of 5 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15CT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000114 ()

  • Special Insulating Length between groups of 5 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15CM

  • Depth electrode
SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000107 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-15AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000077 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AM

  • 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, 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
Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system
MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • 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

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • 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
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
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