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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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RX ACCULINK™ Carotid Stent System 7.0 mm x 20 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011339-20
In Commercial Distribution

  • 08717648076244 ()
1011339-20

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6.0 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-40
In Commercial Distribution

  • 08717648076237 ()
1011338-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6.0 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-30
In Commercial Distribution

  • 08717648076220 ()
1011338-30

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6.0 mm x 20 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-20
In Commercial Distribution

  • 08717648076213 ()
1011338-20

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-40
In Commercial Distribution

  • 08717648076206 ()
1011337-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-30
In Commercial Distribution

  • 08717648076190 ()
1011337-30

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 20 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-20
In Commercial Distribution

  • 08717648076183 ()
1011337-20

  • Bare-metal carotid artery stent
The intended purpose of the Fixture Removal kit is, by an Integrum certified physician, to perform the removal of a Femur Fixture. Consist of instruments: Mounting Tool for Trephine Guide Pins Fixture Mount Screw Fixture Mount Hammer Hammer Handle Fixture Mount Connector Fixture Mount Connector Screw Fixture Mount Handle Spanner 8 mm Spanner 12 mm Spanner 14 mm Spanner 19 mm
Integrum AB
2532
In Commercial Distribution

  • 07340152102034 ()


  • Internal-external leg prosthesis osseointegration bar
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-003
In Commercial Distribution

  • 10855728005892 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-002
In Commercial Distribution

  • 10855728005632 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
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