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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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Post Cement Paste/Paste Chemical Cure Gray Shade
ESSENTIAL DENTAL SYSTEMS, INC.
850-00
Not in Commercial Distribution

  • 00766054000068 ()

  • One 9 gram Syringe Base and One 9 gram Syringe Catalyst
850-00

  • Dental composite resin
Core Material Paste/Paste Chemical Cure Natural Shade A3 Fast Set
ESSENTIAL DENTAL SYSTEMS, INC.
815-00
In Commercial Distribution

  • 00766054000037 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
815-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Natural Shade A3
ESSENTIAL DENTAL SYSTEMS, INC.
810-00
In Commercial Distribution

  • 00766054000020 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
810-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Gray Shade Fast Set
ESSENTIAL DENTAL SYSTEMS, INC.
805-00
In Commercial Distribution

  • 00766054000013 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
805-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Gray Shade
ESSENTIAL DENTAL SYSTEMS, INC.
800-00
In Commercial Distribution

  • 00766054000006 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
800-00

  • Custom-made dental composite resin kit
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-85-70-N
Not in Commercial Distribution

  • 00685447004707 ()

  • 12.5F 85cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-67-70-N
Not in Commercial Distribution

  • 00685447004691 ()

  • 12.5F 67cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-85-70-N
Not in Commercial Distribution

  • 00685447003038 ()

  • 12.5F 85cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-67-70-N
Not in Commercial Distribution

  • 00685447003021 ()

  • 12.5F 67cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
No Description
Zimmer, Inc.
1179-24
In Commercial Distribution

  • 00889024035164 ()

  • Length: 9 Inch
  • One 3.5 mm Screw Tine
00-1179-024-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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