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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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VersaCross Steerable Sheath - 00685447005490

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

VersaCross Steerable Sheath - 00685447005483

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

VersaCross Transseptal Sheath - 00685447003526

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-37-D1
Not in Commercial Distribution

  • 00685447003526 ()

  • 63cm 8F VersaCross Transseptal Sheath with 37° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003519

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-135-D0
Not in Commercial Distribution

  • 00685447003519 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 135° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003502

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-90-D0
Not in Commercial Distribution

  • 00685447003502 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 90° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003496

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-55-D0
Not in Commercial Distribution

  • 00685447003496 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 55° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003489

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-45-D0
In Commercial Distribution

  • 00685447003489 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 45° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003472

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-37-D0
Not in Commercial Distribution

  • 00685447003472 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 37° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003465

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-135-D0
Not in Commercial Distribution

  • 00685447003465 ()

  • 81cm 8F VersaCross Transseptal Sheath with 135° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003458

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-90-D0
Not in Commercial Distribution

  • 00685447003458 ()

  • 81cm 8F VersaCross Transseptal Sheath with 90° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
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