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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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XableCath - 00853989006040

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
ZIEN MEDICAL TECHNOLOGIES, INC.
XC-018-090A
Not in Commercial Distribution

  • 00853989006040 ()

  • Guidewire Diameter: .018 Inch
  • Catheter Length: 90 Centimeter
XC-018-090A

  • Vascular guide-catheter, single-use

XableCath - 00853989006033

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
ZIEN MEDICAL TECHNOLOGIES, INC.
XC-018-065A
Not in Commercial Distribution

  • 00853989006033 ()

  • Guidewire Diameter: .018 Inch
  • Catheter Length: 65 Centimeter
XC-018-065A

  • Vascular guide-catheter, single-use

XableCath - 00853989006026

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
ZIEN MEDICAL TECHNOLOGIES, INC.
XC-014-145A
Not in Commercial Distribution

  • 00853989006026 ()

  • Guidewire Diameter: .014 Inch
  • Catheter Length: 145 Centimeter
XC-014-145A

  • Vascular guide-catheter, single-use

XableCath - 00853989006019

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
ZIEN MEDICAL TECHNOLOGIES, INC.
XC-014-090A
Not in Commercial Distribution

  • 00853989006019 ()

  • Guidewire Diameter: .014 Inch
  • Catheter Length: 90 Centimeter
XC-014-090A

  • Vascular guide-catheter, single-use

XableCath - 00853989006002

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
ZIEN MEDICAL TECHNOLOGIES, INC.
XC-014-065A
Not in Commercial Distribution

  • 00853989006002 ()

  • Catheter Length: 65 Centimeter
  • Guidewire Diameter: .014 Inch
XC-014-065A

  • Vascular guide-catheter, single-use

ORLocate - 05060356150045

ORLocate Locator Drape with three straps, sterile is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Drape
Not in Commercial Distribution

  • 55060356150040 ()
  • 05060356150045 ()
LC16961

  • Radio-frequency identification reader

ORLocate - 05060356150021

ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Drape
Not in Commercial Distribution

  • 55060356150026 ()
  • 05060356150021 ()
HC12631

  • Radio-frequency identification reader

ORLocate - 05060356150007

ORLocate Locator Drape with two straps, sterile is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Drape
Not in Commercial Distribution

  • 55060356150002 ()
  • 05060356150007 ()
LC16601

  • Radio-frequency identification reader

truFreeze - 00724995199210

16 FR CryoDecompression Tube (CDT) - Low Durometer is used with the truFreeze Spray Cryotherapy System.
US Endoscopy
2000181
In Commercial Distribution

  • 10724995199217 ()
  • 00724995199210 ()
  • 00857068006075 ()
2000181

  • General cryosurgical system, cryogen gas, mechanical

truFreeze - 00724995199203

20 FR CryoDecompression Tube (CDT) Active Venting is used with the truFreeze Spray Cryotherapy System.
US Endoscopy
ACCCC3CDT05
In Commercial Distribution

  • 10724995199200 ()
  • 00724995199203 ()
  • 00857068006037 ()
ACCCC3CDT05

  • General cryosurgical system, cryogen gas, mechanical
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