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, 18 CONTACTS, EXPLORATION LENGTH 61.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000183 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 18 CONTACTS, EXPLORATION LENGTH 61.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000176 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18AM

  • Depth electrode
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, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000091 ()

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

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000084 ()

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

  • 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, 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
microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
FHC, INC.
MTDWZN(BP)(BP11)-00925
In Commercial Distribution

  • 00873263009253 ()
  • 10873263009250 ()
MTDWZN(BP)(BP11)

  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(BP)(BP11)-00924
In Commercial Distribution

  • 10873263009243 ()
  • 00873263009246 ()
MTDWZP(BP)(BP11)

  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AR)(MP7)-00923
In Commercial Distribution

  • 10873263009236 ()
  • 00873263009239 ()
MTDWZP(AR)(MP7)

  • Depth electrode
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
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
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
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump
Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • 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
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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