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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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Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
BAXTER HEALTHCARE CORPORATION
1503350
In Commercial Distribution

  • 50085412096105 ()
  • 00085412096100 ()

  • Total Volume: 5 Milliliter
1503350

  • Collagen haemostatic agent, non-antimicrobial
Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
BAXTER HEALTHCARE CORPORATION
1503349
In Commercial Distribution

  • 00085412096094 ()

  • Total Volume: 5 Milliliter
1503349

  • Collagen haemostatic agent, non-antimicrobial
Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
BAXTER HEALTHCARE CORPORATION
ADS201883
In Commercial Distribution

  • 50085412656309 ()
  • 00085412656304 ()

  • Total Volume: 5 Milliliter
ADS201883

  • Collagen haemostatic agent, non-antimicrobial
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6404-01-300
In Commercial Distribution

  • 00817491021342 ()
  • 00817491023056 ()


  • Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6400-01-300
In Commercial Distribution

  • 00817491021335 ()
  • 00817491021359 ()
N/A

  • Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6403-01-300
Not in Commercial Distribution

  • 00817491021311 ()
FG-6403-01-300

  • Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6402-01-300
In Commercial Distribution

  • 00817491021304 ()
  • 00817491021342 ()
FG-6402-01-300

  • Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6401-01-300
In Commercial Distribution

  • 00817491021328 ()
  • 00817491021298 ()
  • 00817491021359 ()
FG-6401-01-300

  • Implantable glucose monitoring system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-011
In Commercial Distribution

  • 10855728005809 ()
4063

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-010
In Commercial Distribution

  • 10855728005670 ()
4063

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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