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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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Curlin - 10814844001010

Curlin Bolus Cord
ZEVEX INTERNATIONAL, INC.
Curlin Bolus Cord
In Commercial Distribution

  • 10814844001010 ()
56872

  • Patient-controlled analgesia infusion pump

Curlin IV Pump System - 10814844000365

Curlin IV Pump System
ZEVEX INTERNATIONAL, INC.
Curlin Pump
In Commercial Distribution

  • 30814844000376 ()
  • 10814844000365 ()
  • 18148440000361 ()


  • Patient-controlled analgesia infusion pump

Soleo Stim - 04053815003328

No Description
Zimmer MedizinSysteme GmbH
5350
In Commercial Distribution

  • 04053815003328 ()
5350

  • Physical therapy transcutaneous electrical stimulation system, line-powered

SkyWalker - 00850030914323

No Description
Microport Navibot International LLC
NB-10147
In Commercial Distribution

  • 00850030914323 ()
NB-10147

  • Imaging lesion localization marker, external, single-use

N/A - 00850030914255

Marker Box (40)
Microport Navibot International LLC
10035-NB
In Commercial Distribution

  • 00850030914255 ()
10035NB

  • Imaging lesion localization marker, external, single-use

VIZADISC - 00848486001414

KNEE Procedure Tracking Kit
MAKO SURGICAL CORP.
107120
In Commercial Distribution

  • 00848486001414 ()
107120

  • Imaging lesion localization marker, external, single-use

VIZADISC - 00848486002534

HIP Procedure Tracking Kit
MAKO SURGICAL CORP.
107130
In Commercial Distribution

  • 00848486002534 ()
107130

  • Imaging lesion localization marker, external, single-use

7D Surgical FLASH Frame - 00628341520621

No Description
7D Surgical ULC
11-0048
In Commercial Distribution

  • 00628341520621 ()


  • Imaging lesion localization marker, external, single-use

7D Surgical Registration Frame - 00628341520553

No Description
7D Surgical ULC
11-0066
In Commercial Distribution

  • 00628341520553 ()


  • Imaging lesion localization marker, external, single-use

WELL-LIFE - 04719872266051

This device is a TENS/EMS Stimulator via using wireless thnology
WELL-LIFE HEALTHCARE LTD.
WR-2605
Not in Commercial Distribution

  • 04719872266051 ()
  • 94719872266054 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
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