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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.
900-002-008
In Commercial Distribution
- 10855728005403 ()
4323
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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.
900-002-007
In Commercial Distribution
- 10855728005199 ()
4323
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.
The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site.
The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher.
Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
The AbClose - Port Site Closure Device is intended to be used by clinicians through prescription use only.
MEDEON BIODESIGN, INC.
M12
In Commercial Distribution
- 04719872920014 ()
- 04719872920021 ()
- 04719872920076 ()
M12
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-DZ1030P
In Commercial Distribution
- 00858418003393 ()
BiO-DZ1030P
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-DZ1020P
In Commercial Distribution
- 00858418003386 ()
BiO-DZ1020P
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-XYZ151505P
In Commercial Distribution
- 00858418003362 ()
BiO-XYZ151505P
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Bi-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-20G
In Commercial Distribution
- 00858418003348 ()
BiO-20G
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-DZ1040P
In Commercial Distribution
- 00858418003812 ()
BiO-DZ1040P
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-XYZ400606P
In Commercial Distribution
- 00858418003805 ()
BiO-XYZ400606P
- Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
Bi-Ostetic is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-XYZ101040P
In Commercial Distribution
- 00858418003799 ()
BiO-XYZ101040P
- Bone matrix implant, synthetic, non-antimicrobial