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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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HVAD® Pump Surgical Tools - 00888707000185

No Description
Heartware Inc.
1317
Not in Commercial Distribution

  • 00888707000185 ()
1317

  • Implantable ventricular circulatory assist system

HVAD® Pump Surgical Tools - 00888707000154

No Description
Heartware Inc.
1318
Not in Commercial Distribution

  • 00888707000154 ()
1318

  • Implantable ventricular circulatory assist system

Eversense E3 Insertion Tools Kit - 00817491022905

Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
SENSEONICS, INCORPORATED
FG-8300-01-201
In Commercial Distribution

  • 00817491022905 ()
FG-8300-01-201

  • Subcutaneous implantation kit, non-medicated

Eversense® Insertion Tools Tray - 00817491021403

Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
SENSEONICS, INCORPORATED
101973-009
Not in Commercial Distribution

  • 00817491021403 ()
N/A

  • Subcutaneous implantation kit, non-medicated

Eversense® Insertion Tools Kit - 00817491021397

Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
SENSEONICS, INCORPORATED
FG-8211-01-201
In Commercial Distribution

  • 00817491021397 ()
FG-8211-01-201

  • Subcutaneous implantation kit, non-medicated

IQ SYSTEM - 00888233010559

No Description
BIOMET MICROFIXATION, INC
72-1010
In Commercial Distribution

  • 00888233010559 ()
72-1010

  • Disposable battery pack

TiMesh® - 70721902805485

BATTERY 8004105 BPD 5-PACK
MEDTRONIC PS MEDICAL, INC.
8004105
In Commercial Distribution

  • 00721902805486 ()
  • 70721902805485 ()


  • Disposable battery pack

LEVEL ONE, STERILE - 00888118079145

BATTERY PACK, FOR 50-800-0X-07, ALKALINE
KLS-Martin L.P.
50-800-02-71
In Commercial Distribution

  • 00888118079145 ()


  • Disposable battery pack

Stryker Varispeed - 07613252732051

Battery pack for VariSpeed
Stryker Leibinger GmbH & Co. KG
62-50201
In Commercial Distribution

  • 07613252732051 ()
62-50201

  • Disposable battery pack

UNIVERSAL NEURO 2, QUIKDRIVE - 04546540518682

BATTERY PACK 2 FOR QUIKDRIVE
Stryker Leibinger GmbH & Co. KG
62-50113
Not in Commercial Distribution

  • 04546540518682 ()
62-50113

  • Disposable battery pack
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