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The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-005
In Commercial Distribution
- 00810098650175 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-003
In Commercial Distribution
- 00810098650083 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-0051
In Commercial Distribution
- 00810098650014 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly
Delphinus Medical Technologies, Inc
Atlantic
In Commercial Distribution
- 00860000221306 ()
900-00035
- Breast ultrasound imaging system
The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
Pramand LLC
CS-2055
In Commercial Distribution
- 00860010683712 ()
- 00860010683705 ()
- Total Volume: 5 Milliliter
CS-2055
- Dura mater sealant
40mm – 30mm (Classic) Tapered Stent (28mm collar)
Artivion, Inc.
K038896
In Commercial Distribution
- 00877234001321 ()
- Catheter Length: 527 Millimeter
- Aortic Stent Proximal Diameter: 20-35mm
- Aortic Stent Distal Diameter: 20-24mm
- Aortic Stent Minimum Length:159mm
- Aortic Stent Maximum Length: 203mm
- Stent Collar Diameter: 28mm
AMDS4030c
- Bare-metal aortic stent
40mm Straight Stent (24mm collar)
Artivion, Inc.
K039420
In Commercial Distribution
- 00877234001192 ()
- Catheter Length: 527 Millimeter
- Aortic Stent Proximal Diameter: 20-35mm
- Aortic Stent Distal Diameter: 25-35mm
- Aortic Stent Minimum Length:153mm
- Aortic Stent Maximum Length:207mm
- Stent Collar Diameter: 24mm
AMDS40
- Bare-metal aortic stent
BioGlue Surgical Adhesive Applicator Tips
Artivion, Inc.
BGAT-SY
In Commercial Distribution
- 10877234001182 ()
- 00877234001185 ()
- 20877234001189 ()
- Length: 74.25 Millimeter
BGAT-SY
- Open-surgery adhesive/sealant applicator, dual-channel
5mL Syringe and Standard Applicator Tips
Artivion, Inc.
BG3515-5-US
Not in Commercial Distribution
- 00877234000249 ()
- 10877234000246 ()
- Total Volume: 5 Milliliter
BG3515-5-US
- Surgical internal adhesive/sealant, animal-derived
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