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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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UroPass Ureteral Access Sheath 12/14 Fr (4/4.7 mm) x 24 cm (5/PK)
Gyrus ACMI, LLC
61224BX
In Commercial Distribution

  • 00821925005976 ()
  • 00821925035393 ()


  • Ureteral catheter
URO-Pass Ureteral Access Sheath 10/12 Fr (3.3/4 mm) x 24 CM (5/PK)
Gyrus ACMI, LLC
61024BX
In Commercial Distribution

  • 00821925035157 ()
  • 00821925035317 ()


  • Ureteral catheter
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 1-0, 24 mm 3/8 Circle Reverse Cutting Needle
Osteogenics Biomedical Inc
CS330R24
In Commercial Distribution

  • D765CS330R240 ()
  • D765CS330R241 ()

  • 24 mm 3/8 Circle RC Needle
  • USP 1-0 Suture Rod
  • Length: 30 Inch


  • Polyolefin/fluoropolymer suture, monofilament
LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5840-2415
Not in Commercial Distribution

  • 00814112020708 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5840-2417
Not in Commercial Distribution

  • 00814112020692 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
InCORPorate VBR Implant 40 W x 30 L x 24 H mm 10 degree Lordotic
SPINAL ELEMENTS
104-1-40302410
In Commercial Distribution

  • 00840916125929 ()


  • Polymeric spinal interbody fusion cage
InCORPorate VBR Implant 33 W x 28 L x 24 H mm 10 degree Lordotic
SPINAL ELEMENTS
104-1-33282410
In Commercial Distribution

  • 00840916125547 ()


  • Polymeric spinal interbody fusion cage
TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F16. PROCEDURE PACK
Intersurgical Incorporated
3241007
In Commercial Distribution

  • 05030267153985 ()
  • 05030267153671 ()


  • Airway suction catheter
TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F14. PROCEDURE PACK
Intersurgical Incorporated
3241006
In Commercial Distribution

  • 05030267153978 ()
  • 05030267153664 ()


  • Airway suction catheter
TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F12. PROCEDURE PACK
Intersurgical Incorporated
3241005
In Commercial Distribution

  • 05030267154012 ()
  • 05030267153657 ()


  • Airway suction catheter
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