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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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Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)
Cardiac Science Corporation
XELAED003B
In Commercial Distribution

  • 00812394020515 ()
XELAED003B

  • External defibrillation electrode, paediatric, single-use
Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)
Cardiac Science Corporation
XELAED003A
In Commercial Distribution

  • 00812394020171 ()
XELAED003A

  • External defibrillation electrode, paediatric, single-use
Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs, under GE part number
Cardiac Science Corporation
2019199-002
In Commercial Distribution

  • 00812394020591 ()
2019199-002

  • External defibrillation electrode, adult, single-use
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution

  • 00850008997020 ()


  • Implantable pulmonary artery pressure monitoring system
RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution

  • 04260308240164 ()


  • Skin photodynamic therapy lamp
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution

  • 04260308240102 ()


  • Skin photodynamic therapy lamp
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
MERZ NORTH AMERICA, INC.
8071C0K1
In Commercial Distribution

  • M2138071C0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CD1357-40QC
In Commercial Distribution

  • 05414734507967 ()

  • Total Volume: 35 Milliliter
CD1357-40QC

  • Single-chamber implantable defibrillator
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
VR
Not in Commercial Distribution

  • 05414734507950 ()

  • Total Volume: 35 Milliliter
CD1357-40

  • Single-chamber implantable defibrillator
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CD1275-36
In Commercial Distribution

  • 05414734506021 ()

  • Total Volume: 30.6 Milliliter
CD1275-36

  • Single-chamber implantable defibrillator
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