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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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1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-37-D0
Not in Commercial Distribution

  • 00685447003328 ()

  • 63cm 8F VersaCross Transseptal Sheath with 37° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71L-D0
Not in Commercial Distribution

  • 00685447005520 ()

  • 72cm 8.5F VersaCross Steerable Sheath with large curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71M-D0
Not in Commercial Distribution

  • 00685447005506 ()

  • 72cm 8.5F VersaCross Steerable Sheath with medium curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71S-D1
Not in Commercial Distribution

  • 00685447005490 ()

  • 72cm 8.5F VersaCross Steerable Sheath with small curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with large curve


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71S-D0
Not in Commercial Distribution

  • 00685447005483 ()

  • 72cm 8.5F VersaCross Steerable Sheath with small curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-55-D0
In Commercial Distribution

  • 00685447003397 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 55° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-37-D0
Not in Commercial Distribution

  • 00685447003373 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 37° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.
Nucletron B.V.
130002-01
Not in Commercial Distribution

  • 98717213037833 ()
  • 08717213038066 ()
130002

  • Remote-afterloading brachytherapy source
No Description
Promepla
09-0012
In Commercial Distribution

  • 03700512986164 ()
  • 03700512966166 ()
  • 03700512976165 ()
ROWG3502ST228

  • Ureteral catheter
Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc IABs
DATASCOPE CORP.
0884-00-0019-16
In Commercial Distribution

  • 10607567106724 ()

  • Catheter Gauge: 7 French
0884-00-0019-16

  • Vascular catheter introduction set, nonimplantable
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