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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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Minerva Co2 Canisters - 00862393000148

Minerva Co2 Canister (5 Pack)
Minerva Surgical, Inc.
MINCo2C
In Commercial Distribution

  • 00862393000148 ()
  • 10862393000145 ()
MINCo2C

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument

Minerva RF Controller - 00862393000100

MINERVA RF Controller Contents: (1) One MINERVA RF-Controller (1) One Footswitch (1) One Power Cord
Minerva Surgical, Inc.
MIN180S
In Commercial Distribution

  • 00862393000100 ()
MIN180S

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument

Optilume BPH Pre-dilation Catheter - 00853095008150

The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1137
In Commercial Distribution

  • 00853095008150 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 35 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1137-30035

  • Urethral dilatation catheter, non-medicated

BIRMINGHAM HIP RESURFACING (BHR) - 03596010591401

14 MM SPACER
Smith & Nephew, Inc.
90123214
In Commercial Distribution

  • 03596010591401 ()
90123214

  • Orthopaedic implant aiming arm

BIRMINGHAM HIP RESURFACING (BHR) - 03596010591395

12 MM SPACER
Smith & Nephew, Inc.
90123212
In Commercial Distribution

  • 03596010591395 ()
90123212

  • Orthopaedic implant aiming arm

BIRMINGHAM HIP RESURFACING (BHR) - 03596010542175

HEAD CENTRE JIG - 11 SETTINGS SHORT
Smith & Nephew, Inc.
90128255
In Commercial Distribution

  • 03596010542175 ()
90128255

  • Orthopaedic implant aiming arm

BIRMINGHAM HIP RESURFACING (BHR) - 03596010606129

3.2 MM HEAD CENTRE JIG -11 SETTINGS LONG
Smith & Nephew, Inc.
90123260
In Commercial Distribution

  • 03596010606129 ()
90123260

  • Orthopaedic implant aiming arm

BIRMINGHAM HIP - 03596010605993

BIRMINGHAM HIP QUICK WIRE JIG
Smith & Nephew, Inc.
90072510
In Commercial Distribution

  • 03596010605993 ()
90072510

  • Orthopaedic implant aiming arm

BIRMINGHAM HIP RESURFACING (BHR) - 03596010504555

BIRMINGHAM HIP PIN CENTERING JIG
Smith & Nephew, Inc.
901004
In Commercial Distribution

  • 03596010504555 ()
901004

  • Orthopaedic implant aiming arm

NA - 03596010591555

JIG INSERT
Smith & Nephew, Inc.
C6001
In Commercial Distribution

  • 03596010591555 ()
C6001

  • Orthopaedic implant aiming arm
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