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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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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
Root Canal Gel Tube
ESSENTIAL DENTAL SYSTEMS, INC.
1610-00
In Commercial Distribution

  • 00766054000150 ()

  • One - 7.5 gram Gel Tube
1610-00

  • Hygroscopic dental cement
Sensor Wraps;For use with OXI-A/N, OXI-P/I, D-YS.
Covidien LP
POSEY
In Commercial Distribution

  • 10884521144897 ()
  • 20884521521145 ()

  • Product Size, One Size, NA;


  • Transcutaneous blood gas monitor sensor
SONICAID ONE
HUNTLEIGH HEALTHCARE LIMITED
SONICAIDONE
In Commercial Distribution

  • 05051968025265 ()
SONICAIDONE

  • Foetal Doppler system
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230-2B-V02
In Commercial Distribution

  • 07613353214449 ()


  • Dental abrasive air jet system
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230-2B-302
In Commercial Distribution

  • 07613353213183 ()


  • Dental abrasive air jet system
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