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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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BioGlue Surgical Adhesive Delivery Tip Extension
Artivion, Inc.
BGDTE-10
Not in Commercial Distribution

  • 10877234000260 ()
  • 00877234000263 ()

  • Length: 10 Centimeter
BGDTE-10

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Syringe Spreader Tips
Artivion, Inc.
BGST-16
Not in Commercial Distribution

  • 10877234000192 ()
  • 00877234000195 ()

  • 16mm tip width
BGST-16

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Syringe Extender Tips
Artivion, Inc.
BGAT-27-SY
Not in Commercial Distribution

  • 10877234000178 ()
  • 00877234000171 ()

  • Length: 27 Centimeter
BGAT-27-SY

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Applicator Tips
Artivion, Inc.
BGAT-SY
Not in Commercial Distribution

  • 10877234000154 ()
  • 00877234000157 ()

  • Length: 74.25 Millimeter
BGAT-SY

  • Open-surgery adhesive/sealant applicator, dual-channel
The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip.
Artivion, Inc.
HERO 1001
Not in Commercial Distribution

  • 00877234000065 ()

  • Outer Diamter: 19 French
  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 40 Centimeter
HERO 1001

  • Arteriovenous shunt
Delivers electric impulses to tired and sore muscles. The muscles respond to the impulses by contracting and relaxing rhythmically, which sends soothing massage sensations to relieve muscle tension and soreness. Six massage modes with 10 intensity levels each provide various combinations of massage sensaations. The body tends to get accustomed to one particular sensation and will eventually stop responding to it, the different sensations available on this unit ensures that the body does not become desensitized.
SUNPENTOWN INTERNATIONAL, INC.
UC-031
In Commercial Distribution

  • 00876840016231 ()
  • 10876840016238 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
Roche Molecular Systems, Inc.
09040552190
In Commercial Distribution

  • 00875197006896 ()
09040552190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
09040544190
In Commercial Distribution

  • 00875197006889 ()
09040544190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
08688214190
In Commercial Distribution

  • 00875197006254 ()
08688214190

  • Multiple immunocompromised host infection-associated virus nucleic acid IVD, control
XTSCI W3 HATCHET/A6 HAT SATIN STEEL HDL
HU-FRIEDY MFG. CO., LLC
TNCI5421
Not in Commercial Distribution

  • 10889950099589 ()
TNCI5421

  • Dental excavator, reusable
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