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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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primaLOK SP - 00813210021785

primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021778

primaLOK SP 18mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0118-00
In Commercial Distribution

  • 00813210021778 ()

  • Height: 18 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021761

primaLOK SP 15mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0115-00
In Commercial Distribution

  • 00813210021761 ()

  • Height: 15 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021754

primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0112-00
In Commercial Distribution

  • 00813210021754 ()

  • Height: 12 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021747

primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021730

primaLOK SP 8mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0108-00
In Commercial Distribution

  • 00813210021730 ()

  • Height: 8 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021723

primaLOK SP 6mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0106-00
In Commercial Distribution

  • 00813210021723 ()

  • Height: 6 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

inFlow Device - 00862563003146

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump

inFlow Device - 00862563003139

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump

inFlow Device - 00862563003122

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump

inFlow Device - 00862563003115

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump

inFlow Device - 00862563003108

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump

inFlow Device - 00862563003092

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump

inFlow Device - 00862563003085

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump

inFlow Sizing Device - 00862563003078

Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003034

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003027

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

inFlow Intraurethral Valve-Pump - 08625630003003

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003002

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

DEPTHALON® - 00650551130246

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-142
In Commercial Distribution

  • 00650551130246 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-142

  • Depth electrode

DEPTHALON® - 00650551130239

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-143
In Commercial Distribution

  • 00650551130239 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.8 Millimeter
  • Recording Depth 75 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-143

  • Depth electrode

DEPTHALON® - 00650551045809

DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2
In Commercial Distribution

  • 00650551045809 ()

  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 2 Millimeter
2102-08-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045793

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2
In Commercial Distribution

  • 00650551045793 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045786

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2
In Commercial Distribution

  • 00650551045786 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551041993

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108
In Commercial Distribution

  • 00650551041993 ()

  • Spacing 3.5 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 90 Millimeter
2102-16-108

  • Depth electrode

DEPTHALON® - 00650551041986

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-098
In Commercial Distribution

  • 00650551041986 ()

  • Spacing 3.5 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 90 Millimeter
2102-16-098

  • Depth electrode

DEPTHALON® - 00650551041979

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-107
In Commercial Distribution

  • 00650551041979 ()

  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
2102-16-107

  • Depth electrode

DEPTHALON® - 00650551041962

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-097
In Commercial Distribution

  • 00650551041962 ()

  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
2102-16-097

  • Depth electrode

DEPTHALON® - 00650551041955

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-106
In Commercial Distribution

  • 00650551041955 ()

  • Spacing 4.43 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 68.5 Millimeter
2102-16-106

  • Depth electrode

DEPTHALON® - 00650551041948

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-096
In Commercial Distribution

  • 00650551041948 ()

  • Spacing 4.43 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 68.5 Millimeter
2102-16-096

  • Depth electrode
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