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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KneeAlign 2 Unit
Orthalign, Inc.
133631-01
In Commercial Distribution

  • 00810832031376 ()
133631-01

  • Orthopaedic stereotactic surgery system
OrthAlign Plus Unit - Gap Balancing
Orthalign, Inc.
403001-08
In Commercial Distribution

  • 00810832031369 ()
403001-08

  • Orthopaedic surgical procedure kit, non-medicated, reusable
OrthAlign Plus Unit - P3
Orthalign, Inc.
403001-07
In Commercial Distribution

  • 00810832031352 ()
403001-07

  • Orthopaedic stereotactic surgery system
OrthAlign Plus Unit - Gap Balancing
Orthalign, Inc.
403001-06
In Commercial Distribution

  • 00810832030089 ()
  • 00810832030072 ()
403001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
CREO MEDICAL LIMITED
PRD-SB1-003
In Commercial Distribution

  • 05060359561077 ()
  • 00560359561053 ()
  • 05060359561039 ()
  • 05060359561015 ()

  • Length: 1.9 Meter
  • Outer Diameter: 2.4 Millimeter
PRD-SB1-003

  • Endoscopic electrosurgical/microwave submucosal lift/resection instrument
MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
CREO MEDICAL LIMITED
7-NP1-100
In Commercial Distribution

  • 05060359560490 ()
  • 05060359560971 ()
  • 05060359560483 ()

  • Length: 1.9 Meter
  • Outer Diameter: 2.4 Millimeter
7-NP1-100

  • Microwave ablation system probe, non-powered
Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
CREO MEDICAL LIMITED
Speedboat Ultraslim Long (SB1L)
In Commercial Distribution

  • 05060359560650 ()
  • 05060359560643 ()
  • 05060359560636 ()

  • Length: 1.9 Meter
  • Outer Diameter: 2.4 Millimeter
PRD-SB1-001

  • Endoscopic electrosurgical/microwave submucosal lift/resection instrument
OrthAlign Plus Unit
Orthalign, Inc.
403001
In Commercial Distribution

  • 10858704006531 ()
  • 00858704006534 ()
403001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
KneeAlign 2 Unit
Orthalign, Inc.
133631
In Commercial Distribution

  • 10858704006005 ()
  • 00858704006008 ()
133631

  • Orthopaedic stereotactic surgery system
OrthAlign Plus - DAA without Leg Length & Offset
Orthalign, Inc.
403001-04
In Commercial Distribution

  • 10851977007731 ()
  • 00851977007734 ()
403001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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