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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Suture Booties, Pink (Large), Sterile, 5 pair/pad; 5 pads per box
KEY SURGICAL, INC.
VB-1120
Not in Commercial Distribution

  • 10849771021053 ()
  • 00849771021056 ()

  • Lumen/Inner Diameter: .090 Inch
VB1120

  • Vascular booties
Suture Booties, Yellow, Sterile, 5 pair/pad; 5 pads/box
KEY SURGICAL, INC.
VB-1115
In Commercial Distribution

  • 10849771019135 ()
  • 00849771019138 ()

  • Lumen/Inner Diameter: .062 Inch


  • Vascular booties
Suture Booties, Red, Sterile, 5 pair/pad; 5 pads per box
KEY SURGICAL, INC.
VB-1100
Not in Commercial Distribution

  • 10849771016899 ()
  • 00849771016892 ()

  • Lumen/Inner Diameter: .062 Inch
VB1100

  • Vascular booties
Suture Booties, Yellow (2), Sterile, 2 pair/pad; 5 pads/box
KEY SURGICAL, INC.
VB-1215
In Commercial Distribution

  • 10849771014673 ()
  • 00849771014676 ()

  • Lumen/Inner Diameter: .062 Inch


  • Vascular booties
CUSTOM PACK TL1E95R13 CVS P/T
MEDTRONIC, INC.
TL1E95R13
Not in Commercial Distribution

  • 00643169202436 ()


  • Cardiopulmonary bypass system blood tubing set
The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer.
BIOCOMPATIBLES UK LTD
FP00024
In Commercial Distribution

  • 05060116921328 ()


  • Medication transfer set
The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer.
BIOCOMPATIBLES UK LTD
Version 1
Not in Commercial Distribution

  • 05060116921175 ()


  • Medication transfer set
CVS MINOR HEART PK - NO SYR
MEDLINE INDUSTRIES, INC.
DYNJ62413
In Commercial Distribution

  • 10193489657463 ()
  • 40193489657464 ()
DYNJ62413

  • General surgical procedure kit, non-medicated, single-use
CVS PK
Cardinal Health 200, LLC
SCV33CVCR7
In Commercial Distribution

  • 50888439438657 ()
  • 10888439438659 ()
SCV33CVCR7

  • Cardiothoracic surgical procedure kit, medicated, single-use
CVS PK
Cardinal Health 200, LLC
SCV33CVCRL
In Commercial Distribution

  • 50888439432440 ()
  • 10888439432442 ()
SCV33CVCRL

  • Cardiothoracic surgical procedure kit, medicated, single-use
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