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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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BIOPSYBELL SRL - 08033860037499

KYPHOPLASTY TOOL KIT
BIOPSYBELL SRL
VERTEMAX KYPHOPLASTY TOOLS KIT
In Commercial Distribution

  • 08033860037499 ()

  • Needle Gauge: 08 Gauge
VMX-08UK

  • Bone access channel kit

BIOPSYBELL SRL - 08033860037482

KYPHOPLASTY TOOL KIT
BIOPSYBELL SRL
VERTEMAX KYPHOPLASTY TOOLS KIT
In Commercial Distribution

  • 08033860037482 ()

  • Needle Gauge: 10 Gauge
VMX-10UK

  • Bone access channel kit

Stealth System S300 - 00857553006092

StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution

  • 00857553006092 ()
  • 00857553006061 ()
C300/D300

  • Electrocardiographic ambulatory recorder

TatumSurgical/Hand Tool - 00083208010040

Hand Tool #1 Latch Grip Hand Driver 4mm
Suncoast Dental, Inc
Hand Tool / HT.01
In Commercial Distribution

  • 00083208010040 ()

  • Hand Tool #1 to fit latch grip hand tools HT.09/09L/Taps
HT.01

  • Dental implant system

Donor Tube Stripper - 00810020440065

Donor Tube Stripper
Fresenius Kabi AG
6R4452
In Commercial Distribution

  • 00810020440065 ()
6R4452

  • Blood tube stripper

ON-Q* Pain Relief System - 00193494450823

ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
Avanos Medical, Inc.
45082
In Commercial Distribution

  • 10193494450820 ()
  • 00193494450823 ()

  • Total Volume: 400 Milliliter
  • Fill Volume (ml)
PS6508-N

  • Cardiac pulse generator software

IDENTIFY - EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software

LUNA 3D - 04260590372680

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372673

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372673 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372666

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372666 ()
0018438

  • Radiological video camera patient positioning/tracking system
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