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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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Grip-Lok - 10618125192141

Medium Universal Securement with Wide Silicone Adhesive Area
TIDI PRODUCTS, LLC
3300MWA-10PK
In Commercial Distribution

  • 00618125192144 ()
  • 10618125192141 ()
  • 00618125135042 ()
3300MWA-10PK

  • Wearable percutaneous catheter/tube holder

Symphony Centesis Drainage Kit - 00817640021513

Symphony 6F Drainage Kit
URESIL, LLC
CTK-6
Not in Commercial Distribution

  • 00817640020028 ()
  • 20817640021517 ()
  • 00817640021513 ()

  • Catheter Gauge: 6 French
  • Length: 10 Centimeter
CTK-6

  • Pleurocentesis/paracentesis kit

Symphony Centesis Drainage Kit - 00817640021506

Symphony 5F Drainage Kit
URESIL, LLC
CTK-5
Not in Commercial Distribution

  • 00817640020011 ()
  • 20817640021500 ()
  • 00817640021506 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
CTK-5

  • Pleurocentesis/paracentesis kit

Thora-Vent Thoracic Vent - 00817640020820

Thoracic Vent Occlusion Plug
URESIL, LLC
TVOCP
In Commercial Distribution

  • 10817640020827 ()
  • 00817640020820 ()
  • 20817640020824 ()
  • 00817640020790 ()
TVOCP

  • Pneumothorax catheter insertion set

Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima - 00817495024547

Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Candela Corporation
KT77821
In Commercial Distribution

KT77821

  • Dermatological laser beam guiding handpiece

Dermal Single- Use Cartridge 6-Pkg, Profound, - 00817495023892

Dermal Single- Use Cartridge 6-Pkg, Profound,
Candela Corporation
KT76653
In Commercial Distribution

KT76653

  • Multi-modality skin surface treatment system

SubQ Single- Use Cartridge 6-Pkg, Profound - 00817495023885

SubQ Single- Use Cartridge 6-Pkg, Profound
Candela Corporation
KT76663
In Commercial Distribution

KT76663

  • Multi-modality skin surface treatment system

Syringe, 10 mL - 10628678061023

The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Front Line Medical Technologies Inc.
E01P3
In Commercial Distribution


  • Total Volume: 10 Milliliter
E01P3

  • General-purpose syringe, single-use

COBRA-OS™ - 10628678061016

The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Front Line Medical Technologies Inc.
F01P1
In Commercial Distribution


  • Length: 64.9 Centimeter
  • Balloon Catheter Tip Length: 6.4 Centimeter
  • Outer Diameter: 1.35 Millimeter
  • Balloon Diameter: 25 Millimeter
  • Catheter Working Length: 55 Centimeter
F01P1

  • Intravascular occluding balloon catheter, image-guided

COBRA-OS™ - 10628678061009

The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Front Line Medical Technologies Inc.
F01K1
In Commercial Distribution

  • 10628678061009 ()
  • 16286780610009 ()
  • 20628678061006 ()
F01K1

  • Intravascular occluding balloon catheter, image-guided
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