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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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COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD - 00690103020540

No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020540 ()

  • MITRAL ANNULUS DIAMENTER, 32 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 32 MM
460032MM

  • Mitral/tricuspid annuloplasty ring, open-surgery

COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD - 00690103020533

No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020533 ()

  • MITRAL ANNULUS DIAMENTER, 30 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 30 MM
460030MM

  • Mitral/tricuspid annuloplasty ring, open-surgery

COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD - 00690103020526

No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020526 ()

  • MITRAL ANNULUS DIAMENTER, 28 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 28 MM
460028MM

  • Mitral/tricuspid annuloplasty ring, open-surgery

COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD - 00690103020519

No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020519 ()

  • MITRAL ANNULUS DIAMENTER, 26 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 26 MM
460026MM

  • Mitral/tricuspid annuloplasty ring, open-surgery

EPstar Fixed Electrophysiology Catheter with Lumen - 00685447005995

Max guidewire OD 0.035”; 11 electrodes; Electrode spacing: 5-5-5 mm
Baylis Médicale Cie Inc
DLF-6-10-55-95R
In Commercial Distribution

  • 00685447005995 ()

  • Catheter Gauge: 6 French
  • Length: 95 Centimeter
N/A

  • Cardiac mapping catheter, percutaneous, single-use

EPstar Fixed Electrophysiology Catheter with Lumen - 00685447003731

Max guidewire OD 0.035”; 10 electrodes; Electrode spacing: 5-5-5 mm
Baylis Médicale Cie Inc
DLF-6-10-55-65
In Commercial Distribution

  • 00685447003731 ()

  • Length: 65 Centimeter
  • Catheter Gauge: 6 French


  • Cardiac mapping catheter, percutaneous, single-use

EPstar Fixed Electrophysiology Catheter with Lumen - 00685447003724

Max guidewire OD 0.035”; 10 electrodes; Electrode spacing: 2-8-2 mm
Baylis Médicale Cie Inc
DLF-6-10-28-65
In Commercial Distribution

  • 00685447003724 ()

  • Length: 65 Centimeter
  • Catheter Gauge: 6 French


  • Cardiac mapping catheter, percutaneous, single-use

Synergent™ DBM with CCC, 20cc - 10885862094667

No Description
Rti Surgical, Inc.
004950
In Commercial Distribution

  • 10885862094667 ()
632-00-20

  • Bone matrix implant, human-derived

Synergent™ DBM with CCC, 10cc - 10885862094650

No Description
Rti Surgical, Inc.
004940
In Commercial Distribution

  • 10885862094650 ()
632-00-10

  • Bone matrix implant, human-derived

Synergent™ DBM with CCC, 5cc - 10885862094643

No Description
Rti Surgical, Inc.
004935
In Commercial Distribution

  • 10885862094643 ()
632-00-05

  • Bone matrix implant, human-derived
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