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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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Bifix Temp - E22110551

Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1055
In Commercial Distribution

  • E22110551 ()
1055

  • Dental composite resin

DUOLITH® - 07630039101404

The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
In Commercial Distribution

  • 07630039101404 ()
19880.0005

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

DUOLITH® - 07630039101398

The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
In Commercial Distribution

  • 07630039101398 ()
21362.0102

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
  • Dermatological extracorporeal shock wave therapy system

DUOLITH® - 07630039101336

The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
Not in Commercial Distribution

  • 07630039101336 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

DUOLITH® - 07630039101329

The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
Not in Commercial Distribution

  • 07630039101329 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

CHATTANOOGA - 07630039101312

The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
Intelect F-SW USA
In Commercial Distribution

  • 07630039101312 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

IPP-ON® - 10381780051923

The clamp holder is used to grip the implant.
NEWDEAL
239500ND
Not in Commercial Distribution

  • M248239500ND1 ()
  • 10381780051923 ()


  • Surgical implant handling forceps

Viper® Distal Volar Radius Plating System - 10381780065180

The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135018
Not in Commercial Distribution

  • M248281350181 ()
  • 10381780065180 ()

  • 3.5 mm dia x 21.2 mm L; 18 mm thread
28135018

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Viper® Distal Volar Radius Plating System - 10381780065173

The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135016
Not in Commercial Distribution

  • M248281350161 ()
  • 10381780065173 ()

  • 3.5 mm dia x 19.2 mm L; 16 mm thread
28135016

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Viper® Distal Volar Radius Plating System - 10381780065166

The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135014
Not in Commercial Distribution

  • M248281350141 ()
  • 10381780065166 ()

  • 3.5 mm dia x 17.2 mm L; 14 mm thread
28135014

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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