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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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Medi-Trace Cadence - 20192253018865

Medi-Trace Cadence Paediatric Defibrillation electrode (5 PR/PK) - Philips barrell
Cardinal Health 200, LLC
22661P
Not in Commercial Distribution

  • 50192253018866 ()
  • 20192253018865 ()
  • 10192253018868 ()
22661P

  • Electrode conductive skin pad, single-use

Emdogain - 07630031700025

Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® Emdogain 0.15 ml and 5 blunt needles
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031700025 ()

  • Total Volume: 0.15 Milliliter
075.099

  • Periodontal root surface regeneration material

ARTEFILL - 00350224000004

No Description
SUNEVA MEDICAL, INC.
8021
Not in Commercial Distribution

  • 00350224000004 ()
  • 10350224000001 ()
AF0508

  • Dermal tissue reconstructive material, animal-derived

EXCOR® - 04260090041369

Arterial cannula for infants Ø 5/6 mm; L 200 mm
Berlin Heart GmbH
C80G-040m
In Commercial Distribution

  • 04260090041369 ()

  • Lumen/Inner Diameter: 6 Millimeter


  • External ventricular circulatory assist system

EXCOR® - 04260090040539

Apex cannula for infants Ø 5/6 mm; L 220 mm
Berlin Heart GmbH
C14A-040m
In Commercial Distribution

  • 04260090040539 ()

  • Lumen/Inner Diameter: 6 Millimeter


  • External ventricular circulatory assist system

Simplify® Cervical Artificial Disc - 00843285100139

Simplify® Cervical Artificial Disc Size LG, Height 6, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100139 ()

  • Height: 6 Millimeter
  • Angle: 5 degree
LG-6L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100092

Simplify® Cervical Artificial Disc Size MD, Height 6, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100092 ()

  • Height: 6 Millimeter
  • Angle: 5 degree
MD-6L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100016

Simplify® Cervical Artificial Disc Size SM, Height 4, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100016 ()

  • Height: 4 Millimeter
  • Angle: 5 degree
SM-4L

  • Cervical total intervertebral disc prosthesis, modular

R SERIES - 00847946017125

Defibrillator ,MAIN, MANUAL-2, 3/5 LD, STD CONN, AC PWR, DMST
Zoll Medical Corporation
30001000001010012
In Commercial Distribution

  • 00847946017125 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

E SERIES - 00847946007393

Defibrillator ,MAIN, ACLS-3, 3/5 LEAD, GPS, PACE, AC, RAILS, DMST
Zoll Medical Corporation
50000010010124012
In Commercial Distribution

  • 00847946007393 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
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