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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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Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
HISTOLOGICS, LLC
SFT-4500
In Commercial Distribution

  • 10860275000351 ()
  • 00860275000354 ()
SFT-4500

  • Wound debridement tool
Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
HISTOLOGICS, LLC
SFT-4000
In Commercial Distribution

  • 10860275000344 ()
  • 00860275000347 ()
SFT-4000

  • Wound debridement tool
Endocervical curette system (small size) for tissue collection, storage, and transport.
HISTOLOGICS, LLC
SFT-2100
In Commercial Distribution

  • 10860275000337 ()
  • 00860275000330 ()
SFT-2100

  • Endocervical specimen collection kit
Endocervical curette system for tissue collection, storage, and transport.
HISTOLOGICS, LLC
SFT-2000
In Commercial Distribution

  • 10860275000320 ()
  • 00860275000323 ()
SFT-2000

  • Endocervical specimen collection kit
Gynecological biopsy device for tissue collection, storage, and transport.
HISTOLOGICS, LLC
SFT-1000
In Commercial Distribution

  • 10860275000313 ()
  • 00860275000316 ()
SFT-1000

  • Cervical cytology brush
SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.
HISTOLOGICS, LLC
SBX-9000
In Commercial Distribution

  • 00860275000309 ()
  • 10860275000306 ()
SBX-9000

  • Cervical cytology scraper, single-use
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Baylis Médicale Cie Inc
VSTK0029
In Commercial Distribution

  • 00685447012184 ()

  • 63cm 8.5F VersaCross Steerable Sheath with Medium Curl (incl. 85cm Small Curve D0 Dilator; 180cm J-Tip Guidewire OD=0.035in); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft(3m) Connector Cable)


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Baylis Médicale Cie Inc
VSTK0027
In Commercial Distribution

  • 00685447012177 ()

  • 63cm 8.5F VersaCross Steerable Sheath with Large Curl (incl. 85cm Large Curve D1 Dilator; 180cm J-Tip Guidewire OD=0.035in); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft(3m) Connector Cable)


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Baylis Médicale Cie Inc
VSTK0025
In Commercial Distribution

  • 00685447012160 ()

  • 63cm 8.5F VersaCross Steerable Sheath with Large Curl (incl. 85cm Small Curve D0 Dilator; 180cm J-Tip Guidewire OD=0.035in); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft(3m) Connector Cable)


  • Cardiac transseptal access set
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Baylis Médicale Cie Inc
VSTK0024
In Commercial Distribution

  • 00685447012153 ()

  • 72cm 8.5F VersaCross Steerable Sheath with Small Curl (incl. 95cm Large Curve D1 Dilator; 180cm J-Tip Guidewire OD=0.035in); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft(3m) Connector Cable)
NA

  • Cardiac transseptal access set
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